NY State Senate Bill S5657B

Archive: Last Bill Status - In Senate Committee Finance Committee

Introduced
In Committee
On Floor Calendar
- Passed Senate
- Passed Assembly
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Actions

view actions (7)

	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Mar 10, 2020	reported and committed to finance
Feb 19, 2020	print number 5657b
Feb 19, 2020	amend and recommit to health
Jan 08, 2020	referred to health
May 22, 2019	print number 5657a
May 22, 2019	amend and recommit to health
May 10, 2019	referred to health

Votes

view votes

Mar 10, 2020 - Health committee Vote

S5657B

committee

Aye

Nay

Aye with Reservations

Absent

Excused

Abstained

Bill Amendments

Original

B (Active)

Original

B (Active)

S5657 - Details

Current Committee:: Senate Finance
Law Section:: Public Health Law
Laws Affected:: Amd Pub Health L, generally

S5657 - Summary

Provides that medical marihuana may be used as part of the treatment of a patient's condition and removes the "serious" designation of such condition; provides that a practitioner be authorized to prescribe controlled substances in the state and removes the requirement that a physician prescribe such medical marihuana; increases the supply amount of marihuana from thirty to sixty days; allows a designated caregiver facility or designated caregiver facility employee to possess, acquire, deliver, transfer, transport or administer medical marihuana… (view more) requires the commissioner of health to establish a medical marihuana research license; establishes a medical marihuana research program; requires the registration of designated caregiver facilities; authorizes the commissioner of health to approve and permit one or more independent laboratories to test medical marihuana; increases the number of dispensing sites of a registered organization from four to eight; and makes related provisions.

S5657 - Sponsor Memo

 
BILL NUMBER: S5657

SPONSOR: SAVINO
 
TITLE OF BILL:  An act to amend the public health law, in relation to
medical marihuana

 
PURPOSE OR GENERAL IDEA OF BILL:

This bill addresses several problems with the medical marijuana program.
This bill consolidates several proposals from other bills, as well as
changes to the medical program proposed in the 2019 Executive Budget's
Cannabis Regulation and Taxation Act (CRTA).

 
SUMMARY OF SPECIFIC PROVISIONS:

Section 1: Amends PHL § 3360 to:

*Expand eligible conditions to include any condition certified by the
practitioner;
*Allow any practitioner otherwise authorized to prescribe controlled
substances to certify patients for medical marijuana;

*Remove prohibitions on the smoking of medical marijuana; and
*Create the categories of "designated caregiver facility," "designated
caregiver facility employee," and "medical marihuana research program."

Section 2: Amends PHI § 3361 to make conforming changes.

Section 3: Amends PHL § 3362 to:
*Change possession limits from a 30 day to a 60 day supply;
*Authorize possession, acquisition, delivery, transfer, and adminis-
tration of medical marijuana by designated caregiver facilities and
their employees subject to certain requirements; and
*Prohibit smoking of medical marijuana in any place where tobacco may
not be smoked under the Clean Indoor Air Act.

Section 4: Amends PHL § 3363 to:
*Remove the $50 patient application fee for registry ID cards;
*Remove patient-per-caregiver limits when the caregiver is a designated
caregiver facility; and
*Make conforming changes

Section 5: Amends PHL § 3364 to:
*Authorize registered organizations (ROs) to contract out ancillary
functions such as shipping, construction, and security; and
*Make conforming changes

Section 6: Creates a new PHL § 3364-a, "medical marihuana research
licenses," to:
*Establish a medical marijuana research license for purposes of testing,
clinical investigations, and safety and efficacy or genomic or agricul-
tural research relating to medical marijuana; and
*Details application, licensing, and oversight process.

Section 7: Creates a new PHL § 3364-b, "registration of designated care-
giver facilities," to:
*Establishes registration process for "designated caregiver facilities"
among provider types defined in section 1 of the bill; and
*Details application, registration, and oversight process.

Section 8: Creates a new PHL § 3364-c, "laboratory permits," to:
*Detail application, permitting, and oversight process.

Section 9: Amends PHI § 3365 to:
*Increase dispensaries per RO from 4 to 8; and
*Direct the Commissioner to register additional ROs reflecting the demo-
graphics of the state.

Section 10: Amends PHL § 3365-a to make conforming changes.

Section 11: Amends PHL § 3369 to make conforming changes.

Section 12: Amends PHL § 3369-d to remove prior approval of medical
marijuana prices; maintain requirement for ROs to document price chang-
es; and maintain the commissioner's power to modify prices if necessary
to maintain access.

Section 13: Effective date.

 
JUSTIFICATION:

Open conditions list: There is no pharmaceutical other than medical
marijuana for which the State restricts its use to a limited list of
conditions. Setting a conditions list in statute takes medical decisions
out of the hands of the practitioners who know their patients best and
whose judgment the law respects for much more dangerous drugs. Practi-
tioners also lack clarity about which conditions are actually covered.
For example, the Public Health Law definition of "severe or chronic
pain" is inconsistent with regulatory language for "severe debilitating
pain that degrades health and functional capability."

This bill would maintain the naming of several conditions in statute for
illustrative purposes, including some added in the Governor's 2019
Cannabis Regulation and Taxation Act (CRTA), but also allows "any other
condition certified by the practitioner." While the drafting is differ-
ent, the effect is the same as A.1125-A of 2019.

Expanded practitioner list: Today, physicians, physician assistants, and
nurse practitioners can certify patients. However, there are other cate-
gories of practitioner outside these who are authorized to prescribe
much more dangerous substances and often treat conditions for which a
patient may be eligible (such as podiatrists and dentists whose treat-
ments involve pain medication.) This bill expands the practitioner cate-
gories to cover these groups, similar to A.1149 of 2019.

Strike patient registry fees; increase supply from 30 to 60 days:
Current law requires a $50 application fee for registry identification
cards and limits patients to a 30 day supply. While the application fee
is often waived, it presents a barrier to access that does not exist for
patients with any other pharmaceutical product. Current law also limits
patients to acquiring 30 day supplies at once. For patients with limited
mobility, or who may have to travel long distances, this limits access.
The 2019 Executive budget proposed Cannabis Regulation and Taxation Act
(CRTA) included both of these changes.

Allow smoking: For some patients, smoking is the most affordable deliv-
ery method and enable them to effectively limit dosage. Out of over 30
states that now have medical marijuana programs, only 4 disallow smoking
as New York does. While smoking can involve respiratory or other issues,
the quantities involved in medical marijuana use are very limited, and
should be a matter between patient and practitioner. This legislation
would protect the public by making medical marihuana smoking subject to
the Clean Indoor Air Act restrictions, similar to A.1032 of 2019.

Facility caregivers: Current law allows patients to designate up to two
people as caregivers under the program. Caregivers are capped at five
patients each. These caps have caused problems administering medical
marijuana in residential facilities or hospitals where there may be more
than five patients using medical marijuana for a given caregiver, or
where a patient may see more than two potential caregiver personnel
(e.g., nurses) on a regular basis. This bill authorizes, but does not
mandate, certain facilities to become "designated caregiver facilities,"
exempting them from such restrictions, similar to A.1131 of 2019 and
language in the CRTA.

Research licenses: While there is significant research being done over-
seas, medical marijuana research in the United States is limited.  This
bill would facilitate medical marijuana research in New York based on
departmental regulations. Both A.1131 of 2019 and the CRTA also author-
ize research licenses.

Expanded lab testing: Today, the State's Wadsworth Laboratory is the
only lab authorized to test medical marijuana. As the program expands,
more lab capacity is needed. Commercial labs with Drug Enforcement Agen-
cy (DEA) licenses may be reluctant to test medical marijuana out of fear
of endangering these DEA licenses. This bill removes the requirement
that a lab which tests medical marijuana hold a DEA license and details
State permitting of labs for medical marijuana testing, similar to both
A.1131 of 2019 and the CRTA.

RO contracting: Registered organizations (R0s) are currently not allowed
to contract out any part of the production and distribution processes.
This is contrary to standard business practice, is inefficient and rais-
es costs. This bill allows ROs to contract out ancillary functions, such
as security or transportation, while ensuring that laws applicable to
the RO for the purpose of those services would apply to the contractors
as well. This is similar to both A.1131 of 2019 and the CRTA.

Increased dispensaries and ROs: Current law authorizes up to four
dispensaries for each of the 10 ROs that engages in manufacturing.  This
places New York far below every other state medical marijuana programs
for dispensary access per population. For comparison, New York has
approximately 500,000 people per dispensary versus 233,000 to 1 in Illi-
nois; 192,000 in Michigan, and 70,000 in Florida. This bill would double
the number from 4 to 8 per RO. The bill also directs the commissioner to
register additional ROs "reflecting the demographics of the state."
While current law does authorize the registration of additional ROs,
this explicit direction signals the importance of greater minority and
women-owned participation in the medical marijuana program. The dispen-
sary expansion is also found in A.1131 of 2019.

Modifying price controls: Current law authorizes price setting by the
commissioner and prohibits any sale not in accordance with such prices.
In practice, ROs submit prices and price changes to the department for
approval. Since enactment, not one price setting or proposed change has
ever been rejected. But it takes weeks or even months for ROs to get
approvals, during which time they either cannot roll out new products or
cannot sell existing products at their new, typically lower prices
(nearly all price changes are downward.) This bill repeals the require-
ment for prior approval of price changes; maintains reporting of all
price changes to the department; and maintains the commissioner's
authority to reject or modify prices if necessary to maintain access.

 
PRIOR LEGISLATIVE HISTORY:

New bill

 
FISCAL IMPLICATIONS:

Minimal. Minor reduction in patient registration fees ($50 each); likely
revenue increase from licensing of additional ROs and fees associated
with new license categories.

 
EFFECTIVE DATE:
Immediate.

S5657 - Bill Text download pdf


                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  5657

                       2019-2020 Regular Sessions

                            I N  S E N A T E

                              May 10, 2019
                               ___________

Introduced  by  Sen.  SAVINO -- read twice and ordered printed, and when
  printed to be committed to the Committee on Health

AN ACT to amend the public health law, in relation to medical marihuana

  THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section  1.  Subdivisions 1, 5, 7 and 12 of section 3360 of the public
health law, subdivisions 1, 5, 7 and 12 as added by chapter  90  of  the
laws  of  2014, paragraph (a) of subdivision 7 as amended by chapter 273
of the laws of 2018, are amended and three new subdivisions 5-a, 5-b and
19 are added to read as follows:
  1. "Certified medical use" means the acquisition, possession, use, or,
transportation of medical marihuana  by  a  certified  patient,  or  the
acquisition,  possession,  delivery, transportation or administration of
medical marihuana by a designated caregiver, for  use  as  part  of  the
treatment  of  the  patient's  [serious]  condition,  as authorized in a
certification under this title including enabling the patient to  toler-
ate treatment for the [serious] condition. [A certified medical use does
not include smoking.]
  5.  "Designated  caregiver" means the individual OR CAREGIVER FACILITY
designated by a certified patient in a registry application. A certified
patient may designate up to two designated caregivers,  NOT  COUNTING  A
DESIGNATED CAREGIVER FACILITY OR DESIGNATED CAREGIVER FACILITY EMPLOYEE.
  5-A.  "DESIGNATED  CAREGIVER  FACILITY" MEANS AN ENTITY THAT REGISTERS
WITH THE COMMISSIONER TO ASSIST ONE OR MORE CERTIFIED PATIENTS WITH  THE
ACQUISITION,  POSSESSION,  DELIVERY, TRANSPORTATION OR ADMINISTRATION OF
MEDICAL MARIHUANA AND IS: A GENERAL HOSPITAL OR RESIDENTIAL HEALTH  CARE
FACILITY  OPERATING UNDER ARTICLE TWENTY-EIGHT OF THIS CHAPTER; AN ADULT
CARE FACILITY OPERATING UNDER TITLE TWO OF ARTICLE SEVEN OF  THE  SOCIAL
SERVICES  LAW;  A  COMMUNITY  MENTAL  HEALTH RESIDENCE ESTABLISHED UNDER
SECTION 41.44 OF THE MENTAL HYGIENE  LAW;  A  HOSPITAL  OPERATING  UNDER
SECTION  7.17 OF THE MENTAL HYGIENE LAW; A MENTAL HYGIENE FACILITY OPER-

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.

                                                           LBD11129-03-9

S. 5657                             2

ATING UNDER ARTICLE THIRTY-ONE OF THE MENTAL HYGIENE LAW;  AN  INPATIENT
OR  RESIDENTIAL  TREATMENT PROGRAM CERTIFIED UNDER ARTICLE THIRTY-TWO OF
THE MENTAL HYGIENE LAW; A RESIDENTIAL FACILITY FOR THE CARE  AND  TREAT-
MENT  OF PERSONS WITH DEVELOPMENTAL DISABILITIES OPERATING UNDER ARTICLE
SIXTEEN OF THE MENTAL HYGIENE LAW; A RESIDENTIAL TREATMENT FACILITY  FOR
CHILDREN  AND  YOUTH  OPERATING  UNDER  ARTICLE THIRTY-ONE OF THE MENTAL
HYGIENE LAW; A PUBLIC SCHOOL  OR  PRIVATE  SCHOOL  OPERATING  UNDER  THE
EDUCATION  LAW;  A RESEARCH INSTITUTION WITH AN INTERNAL REVIEW BOARD; A
MEDICAL MARIHUANA RESEARCH PROGRAM LICENSED UNDER  SECTION  THIRTY-THREE
HUNDRED  SIXTY-FOUR-A OF THIS TITLE; OR ANY OTHER FACILITY AS DETERMINED
BY THE COMMISSIONER IN REGULATION.
  5-B. "DESIGNATED CAREGIVER FACILITY EMPLOYEE" MEANS AN EMPLOYEE  OF  A
DESIGNATED CAREGIVER FACILITY.
  7. (a) ["Serious condition"] "CONDITION" means:
  (i) having one of the following [severe debilitating or life-threaten-
ing]  conditions:  cancer,  positive  status  for human immunodeficiency
virus or acquired immune deficiency syndrome, amyotrophic lateral scler-
osis, Parkinson's disease, multiple sclerosis,  damage  to  the  nervous
tissue  of  the  spinal  cord  with objective neurological indication of
intractable spasticity, epilepsy, inflammatory bowel  disease,  neuropa-
thies,  Huntington's  disease, post-traumatic stress disorder, pain that
degrades health and functional capability where the use of medical mari-
huana  is  an  alternative  to  opioid  use,  substance  use   disorder,
ALZHEIMER'S, MUSCULAR DYSTROPHY, DYSTONIA, RHEUMATOID ARTHRITIS, AUTISM,
or [as added by the commissioner; and
  (ii) any of the following conditions where it is clinically associated
with,  or  a  complication  of,  a condition under this paragraph or its
treatment: cachexia or wasting syndrome; severe or chronic pain;  severe
nausea; seizures; severe or persistent muscle spasms; or such conditions
as are added by the commissioner.
  (b)  No  later  than  eighteen  months from the effective date of this
section, the commissioner shall determine whether to add  the  following
serious  conditions:  Alzheimer's,  muscular  dystrophy, dystonia, post-
traumatic stress disorder and rheumatoid arthritis] ANY OTHER  CONDITION
CERTIFIED BY THE PRACTITIONER.
  12.  "Practitioner"  means  a  practitioner  who  (i)  [is a physician
licensed by New York state and practicing within the state,] IS  AUTHOR-
IZED  TO PRESCRIBE CONTROLLED SUBSTANCES WITHIN THE STATE; (ii) [who] by
training or experience is qualified to treat a  [serious]  condition  as
defined in subdivision seven of this section; and (iii) [has completed a
two  to four hour course as determined by the commissioner in regulation
and registered with the department;  provided  however,  a  registration
shall  not  be  denied without cause. Such course may count toward board
certification requirements. The commissioner shall consider  the  inclu-
sion  of  nurse practitioners under this title based upon considerations
including access and availability. After such consideration the  commis-
sioner  is authorized to deem nurse practitioners as practitioners under
this title] COMPLETES, AT A MINIMUM, A TWO HOUR COURSE AS DETERMINED  BY
THE  COMMISSIONER.  A PERSON'S STATUS AS A PRACTITIONER UNDER THIS TITLE
IS DEEMED TO BE A "LICENSE" FOR PURPOSES OF SECTION THIRTY-THREE HUNDRED
NINETY OF THIS ARTICLE.
  19. "MEDICAL MARIHUANA RESEARCH PROGRAM"  MEANS  A  MEDICAL  MARIHUANA
RESEARCH   PROGRAM   LICENSED   UNDER   SECTION   THIRTY-THREE   HUNDRED
SIXTY-FOUR-A OF THIS TITLE.
  § 2. Subdivisions 1, 2, and 9 of section 3361  of  the  public  health
law, subdivisions 1 and 2 as added by chapter 90 of the laws of 2014 and

S. 5657                             3

subdivision  9  as added by chapter 416 of the laws of 2015, are amended
to read as follows:
  1.  A  patient certification may only be issued if: (a) a practitioner
has been registered with the department  to  issue  a  certification  as
determined  by  the commissioner; (b) the patient has a [serious] condi-
tion, which shall be specified in the patient's health care record;  (c)
the  practitioner  by  training  or experience is qualified to treat the
[serious] condition; (d) the patient is under the practitioner's contin-
uing care for the [serious] condition; and  (e)  in  the  practitioner's
professional opinion and review of past treatments, the patient is like-
ly  to  receive  therapeutic  or  palliative benefit from the primary or
adjunctive treatment with medical use of  marihuana  for  the  [serious]
condition.
  2.  The  certification  shall  include (a) the name, date of birth and
address of the patient; (b) a statement that the patient has a [serious]
condition and the patient is  under  the  practitioner's  care  for  the
[serious]  condition; (c) a statement attesting that all requirements of
subdivision one of this section have been satisfied; (d) the  date;  and
(e)  the  name,  address, federal registration number, telephone number,
and the  handwritten  signature  of  the  certifying  practitioner.  The
commissioner  may  require by regulation that the certification shall be
on a form provided by the department. The practitioner may state in  the
certification  that,  in  the  practitioner's  professional opinion, the
patient would benefit from medical  marihuana  only  until  a  specified
date. The practitioner may state in the certification that, in the prac-
titioner's  professional opinion, the patient is terminally ill and that
the certification shall not expire until the patient dies.
  9.(a) A certification may be a special certification if,  in  addition
to  the  other requirements for a certification, the practitioner certi-
fies in the certification that  the  patient's  [serious]  condition  is
progressive  and  degenerative  or that delay in the patient's certified
medical use of marihuana poses a serious risk to the patient's  life  or
health.
  (b)  The  department  shall  create  the form to be used for a special
certification and shall make that form available to be  downloaded  from
the department's website.
  § 3. Subdivisions 1 and 2 of section 3362 of the public health law, as
added  by chapter 90 of the laws of 2014, are amended and a new subdivi-
sion 3 is added to read as follows:
  1. The possession, acquisition, use, delivery,  transfer,  transporta-
tion,  or  administration of medical marihuana by a certified patient or
designated caregiver possessing a valid  registry  identification  card,
for  certified  medical  use, shall be lawful under this title; provided
that:
  (a) the marihuana that may be possessed by a certified  patient  shall
not  exceed  a  [thirty] SIXTY day supply of the dosage as determined by
the practitioner, consistent with any guidance and regulations issued by
the commissioner, provided that during the last seven days of any [thir-
ty] SIXTY day period, the certified patient may also possess up to  such
amount for the next [thirty] SIXTY day period;
  (b)  the marihuana that may be possessed by designated caregivers does
not exceed the quantities referred to in paragraph (a) of this  subdivi-
sion for each certified patient for whom the caregiver possesses a valid
registry identification card, up to five certified patients;
  (C) THE MARIHUANA THAT MAY BE POSSESSED BY DESIGNATED CAREGIVER FACIL-
ITIES  DOES  NOT  EXCEED  THE QUANTITIES REFERRED TO IN PARAGRAPH (A) OF

S. 5657                             4

THIS SUBDIVISION FOR EACH CERTIFIED PATIENT UNDER CARE OR  TREATMENT  OF
THE FACILITY;
  [(c)] (D) the form or forms of medical marihuana that may be possessed
by the certified patient [or], designated caregiver, OR DESIGNATED CARE-
GIVER  FACILITY  pursuant to a certification shall be in compliance with
any recommendation or limitation by the practitioner as to the  form  or
forms  of  medical  marihuana or dosage for the certified patient in the
certification; and
  [(d)] (E) the medical marihuana shall be kept in the original  package
in  which  it  was dispensed under subdivision twelve of section thirty-
three hundred sixty-four of this title, except for the  portion  removed
for  immediate  consumption  for  certified medical use by the certified
patient.
  2. Notwithstanding subdivision one of this section:
  (a) possession of medical marihuana shall not  be  lawful  under  this
title  if it is smoked, consumed, vaporized, or grown in a public place,
regardless of the form of medical  marihuana  stated  in  the  patient's
certification.
  (b)  a  [person]  CERTIFIED PATIENT OR DESIGNATED CAREGIVER possessing
medical marihuana under this title shall possess  his  or  her  registry
identification card at all times when in immediate possession of medical
marihuana.
  (C) MEDICAL MARIHUANA MAY NOT BE SMOKED IN ANY PLACE WHERE TOBACCO MAY
NOT  BE  SMOKED  UNDER ARTICLE THIRTEEN-E OF THIS CHAPTER, REGARDLESS OF
THE FORM OF MEDICAL MARIHUANA STATED IN THE PATIENT'S CERTIFICATION.
  3. THE POSSESSION, ACQUISITION, DELIVERY, TRANSFER, TRANSPORTATION, OR
ADMINISTRATION OF MEDICAL MARIHUANA BY A DESIGNATED  CAREGIVER  FACILITY
OR  DESIGNATED  CAREGIVER  FACILITY  EMPLOYEE SHALL BE LAWFUL UNDER THIS
TITLE PROVIDED THAT:
  (A) THE DESIGNATED CAREGIVER FACILITY REGISTERS WITH THE DEPARTMENT ON
A FORM PROVIDED BY THE COMMISSIONER;
  (B) SUCH POSSESSION, ACQUISITION, DELIVERY, TRANSFER,  TRANSPORTATION,
OR  ADMINISTRATION  IS  ON  BEHALF  OF  A CERTIFIED PATIENT POSSESSING A
REGISTRY IDENTIFICATION CARD;
  (C) THE DESIGNATED CAREGIVER FACILITY MAINTAINS A COPY OF THE REGISTRY
IDENTIFICATION CARD OF EACH CERTIFIED PATIENT FOR  WHICH  IT  POSSESSES,
ACQUIRES,  DELIVERS, TRANSFERS, TRANSPORTS, OR ADMINISTERS MEDICAL MARI-
HUANA; AND
  (D) A DESIGNATED CAREGIVER FACILITY EMPLOYEE SHALL BE IDENTIFIED AS AN
EMPLOYEE WHEN NECESSARY, AS PROVIDED BY THE COMMISSIONER.
  § 4. Subdivisions 2, 3, 5, and 11 of section 3363 of the public health
law, as added by chapter 90 of the laws of 2014, are amended to read  as
follows:
  2.  To obtain, amend or renew a registry identification card, a certi-
fied patient or designated caregiver shall file a  registry  application
with  the  department.  The  registry application or renewal application
shall include:
  (a) in the case of a certified patient:
  (i) the patient's certification (a new written certification shall  be
provided with a renewal application);
  (ii) the name, address, and date of birth of the patient;
  (iii) the date of the certification;
  (iv)  if  the  patient  has  a registry identification card based on a
current valid certification,  the  registry  identification  number  and
expiration date of that registry identification card;

S. 5657                             5

  (v)  the  specified  date  until  which the patient would benefit from
medical marihuana, if the certification states such a date;
  (vi)  the  name,  address,  federal registration number, and telephone
number of the certifying practitioner;
  (vii) any recommendation or limitation by the practitioner as  to  the
form  or forms of medical marihuana or dosage for the certified patient;
and
  (viii)  other  individual  identifying  information  required  by  the
department;
  (b)  (I) in the case of a certified patient, if the patient designates
a designated caregiver, the name, address, and  date  of  birth  of  the
designated  caregiver,  and  other  individual  identifying  information
required by the department;
  (II) IF THE DESIGNATED  CAREGIVER  IS  A  MEDICAL  MARIHUANA  RESEARCH
PROGRAM,  THE  NAME  OF  THE  ORGANIZATION  CONDUCTING THE RESEARCH; THE
ADDRESS, PHONE NUMBER, AND NAME OF THE INDIVIDUAL LEADING  THE  RESEARCH
OR  APPROPRIATE  DESIGNEE; AND OTHER IDENTIFYING INFORMATION REQUIRED BY
THE DEPARTMENT;
  (c) in the case of a designated caregiver:
  (i) the name, address, and date of birth of the designated caregiver;
  (ii) if the designated caregiver has a registry  identification  card,
the  registry identification number and expiration date of that registry
identification card; and
  (iii) other individual identifying information required by the depart-
ment;
  (d) a statement that a false statement  made  in  the  application  is
punishable under section 210.45 of the penal law;
  (e)  the  date  of  the application and the signature of the certified
patient or designated caregiver, as the case may be; AND
  (f) [a fifty dollar application fee, provided, that the department may
waive or reduce the fee in cases of financial hardship; and
  (g)] any other requirements determined by the commissioner.
  3. Where a certified patient is under the age of eighteen:
  (a) The application for a registry identification card shall  be  made
by  an  appropriate person over twenty-one years of age. The application
shall state facts demonstrating that the person is appropriate.
  (b) The designated caregiver shall be (i) a parent or  legal  guardian
of  the certified patient, (ii) a person designated by a parent or legal
guardian, [or] (iii) IN THE CASE OF SUCH A CERTIFIED PATIENT BEING CARED
FOR BY A DESIGNATED CAREGIVER FACILITY, THE DESIGNATED CAREGIVER FACILI-
TY DESIGNATED BY THE PARENT OR LEGAL GUARDIAN; OR  (IV)  an  appropriate
person  approved  by  the  department  upon a sufficient showing that no
parent or legal guardian is appropriate or available.
  5. No person may be a designated caregiver for more than  five  certi-
fied  patients  at one time; PROVIDED HOWEVER THAT THIS LIMITATION SHALL
NOT APPLY TO A DESIGNATED CAREGIVER  FACILITY  OR  DESIGNATED  CAREGIVER
FACILITY EMPLOYEE.
  11.  A certified patient or designated caregiver who has been issued a
registry identification card shall notify the department of  any  change
in  his or her name or address or, with respect to the patient, if he or
she ceases to have the [serious] condition noted  on  the  certification
within  ten  days  of such change. The certified patient's or designated
caregiver's registry identification card shall  be  deemed  invalid  and
shall be returned promptly to the department.

S. 5657                             6

  § 5. Subdivisions 3 and 5 of section 3364 of the public health law, as
added  by chapter 90 of the laws of 2014, are amended and a new subdivi-
sion 14 is added to read as follows:
  3.  Each  registered  organization  shall contract with an independent
laboratory PERMITTED UNDER SECTION THIRTY-THREE HUNDRED SIXTY-FOUR-C  OF
THIS  CHAPTER  to  test the medical marihuana produced by the registered
organization. The commissioner shall approve the laboratory and  require
that the laboratory report testing results in a manner determined by the
commissioner. The commissioner is authorized to issue regulation requir-
ing the laboratory to perform certain tests and services.
  5.  (a)  No  registered  organization may sell, deliver, distribute or
dispense to any certified patient or designated caregiver a quantity  of
medical  marihuana  larger  than  that  individual  would  be allowed to
possess under this title.
  (b) When dispensing medical marihuana to a certified patient or desig-
nated caregiver, the registered organization (i) shall not  dispense  an
amount  greater  than a [thirty] SIXTY day supply to a certified patient
until the certified patient has exhausted all but  a  seven  day  supply
provided  pursuant  to a previously issued certification, and (ii) shall
verify the information in subparagraph (i) of this paragraph by consult-
ing the prescription monitoring program registry under  section  thirty-
three hundred forty-three-a of this article.
  (c)  Medical  marihuana dispensed to a certified patient or designated
caregiver by a registered organization shall conform to any  recommenda-
tion  or  limitation  by  the  practitioner  as  to the form or forms of
medical marihuana or dosage for the certified patient.
  14. A REGISTERED ORGANIZATION MAY CONTRACT WITH A PERSON OR ENTITY  TO
PROVIDE  FACILITIES,  EQUIPMENT  OR  SERVICES  THAT ARE ANCILLARY TO THE
REGISTERED ORGANIZATION'S FUNCTIONS OR  ACTIVITIES  UNDER  THIS  SECTION
(INCLUDING,  BUT  NOT  LIMITED  TO, SHIPPING, MAINTENANCE, CONSTRUCTION,
REPAIR, AND SECURITY). ALL  LAWS  AND  REGULATIONS  APPLICABLE  TO  SUCH
FACILITIES,  EQUIPMENT,  OR  SERVICES  SHALL  APPLY TO THE CONTRACT. THE
REGISTERED ORGANIZATION AND OTHER PARTIES TO THE CONTRACT SHALL EACH  BE
RESPONSIBLE  FOR  COMPLIANCE  WITH  SUCH  LAWS AND REGULATIONS UNDER THE
CONTRACT. THE COMMISSIONER MAY MAKE  REGULATIONS  CONSISTENT  WITH  THIS
TITLE RELATING TO CONTRACTS AND PARTIES TO CONTRACTS UNDER THIS SUBDIVI-
SION.
  §  6.  The public health law is amended by adding a new section 3364-a
to read as follows:
  § 3364-A. MEDICAL MARIHUANA RESEARCH LICENSES.   1.  THE  COMMISSIONER
SHALL  ESTABLISH  A  MEDICAL  MARIHUANA  RESEARCH LICENSE THAT PERMITS A
LICENSEE TO PRODUCE, PROCESS,  PURCHASE,  POSSESS,  TRANSFER,  AND  SELL
MARIHUANA,  SUBJECT  TO THIS SECTION, FOR THE FOLLOWING LIMITED RESEARCH
PURPOSES:
  (A) TO TEST CHEMICAL POTENCY AND COMPOSITION LEVELS;
  (B) TO CONDUCT CLINICAL INVESTIGATIONS OF MARIHUANA-DERIVED PRODUCTS;
  (C) TO CONDUCT RESEARCH ON THE EFFICACY AND  SAFETY  OF  ADMINISTERING
MARIHUANA AS PART OF MEDICAL TREATMENT; OR
  (D)  TO  CONDUCT  GENOMIC OR AGRICULTURAL RESEARCH RELATING TO MEDICAL
MARIHUANA.
  2. AS PART OF THE APPLICATION PROCESS FOR A MEDICAL MARIHUANA RESEARCH
LICENSE, AN APPLICANT MUST SUBMIT TO THE COMMISSIONER A  DESCRIPTION  OF
THE  RESEARCH  THAT IS INTENDED TO BE CONDUCTED AS WELL AS THE AMOUNT OF
MARIHUANA TO BE GROWN OR PURCHASED. THE  COMMISSIONER  SHALL  REVIEW  AN
APPLICANT'S RESEARCH PROJECT AND DETERMINE WHETHER IT MEETS THE REQUIRE-

S. 5657                             7

MENTS  OF SUBDIVISION ONE OF THIS SECTION. IN ADDITION, THE COMMISSIONER
SHALL ASSESS THE APPLICATION BASED ON THE FOLLOWING CRITERIA:
  (A) PROJECT QUALITY, STUDY DESIGN, VALUE, AND IMPACT;
  (B)  WHETHER  THE  APPLICANT HAS THE APPROPRIATE PERSONNEL, EXPERTISE,
FACILITIES AND INFRASTRUCTURE,  FUNDING,  AND  (TO  THE  EXTENT  LEGALLY
AVAILABLE)  APPROVALS  RELATING TO HUMAN OR ANIMAL RESEARCH, IN PLACE TO
SUCCESSFULLY CONDUCT THE PROJECT; AND
  (C) WHETHER THE AMOUNT OF MARIHUANA TO BE GROWN OR  PURCHASED  BY  THE
APPLICANT IS CONSISTENT WITH THE PROJECT'S SCOPE AND GOALS.
  3.  IF THE COMMISSIONER DETERMINES THAT THE RESEARCH PROJECT MEETS THE
REQUIREMENTS OF SUBDIVISION ONE OF THIS SECTION,  THE  COMMISSIONER  MAY
APPROVE THE APPLICATION. IF NOT, THE APPLICATION SHALL BE DENIED.
  4.  A  MEDICAL  MARIHUANA  RESEARCH LICENSEE MAY ONLY SELL OR TRANSFER
MARIHUANA GROWN OR PRODUCED WITHIN ITS OPERATION TO OTHER MEDICAL  MARI-
HUANA  RESEARCH  LICENSEES,  OR OTHERWISE FOR PURPOSES OF THE LICENSEE'S
RESEARCH.
  5. IN ESTABLISHING A MEDICAL MARIHUANA RESEARCH LICENSE,  THE  COMMIS-
SIONER MAY MAKE REGULATIONS ON THE FOLLOWING:
  (A) APPLICATION REQUIREMENTS;
  (B)   LICENSE   RENEWAL  REQUIREMENTS,  INCLUDING  WHETHER  ADDITIONAL
RESEARCH PROJECTS MAY BE ADDED OR CONSIDERED;
  (C) CONDITIONS FOR LICENSE REVOCATION;
  (D) SECURITY MEASURES TO ENSURE MARIHUANA IS NOT DIVERTED TO  PURPOSES
OTHER THAN RESEARCH;
  (E)  AMOUNT  OF  PLANTS, USEABLE MARIHUANA, MARIHUANA CONCENTRATES, OR
MARIHUANA-INFUSED PRODUCTS A LICENSEE MAY HAVE ON ITS PREMISES;
  (F) LICENSEE REPORTING REQUIREMENTS;
  (G) CONDITIONS UNDER WHICH MARIHUANA GROWN BY LICENSED  MEDICAL  MARI-
HUANA  PRODUCERS AND OTHER PRODUCT TYPES FROM LICENSED MEDICAL MARIHUANA
PROCESSORS MAY BE DONATED TO MEDICAL MARIHUANA RESEARCH LICENSEES; AND
  (H) ANY ADDITIONAL REQUIREMENTS DEEMED NECESSARY BY THE COMMISSIONER.
  6. A MARIHUANA RESEARCH LICENSE ISSUED UNDER  THIS  SECTION  SHALL  BE
ISSUED  IN THE NAME OF THE APPLICANT OR APPLICANTS, SPECIFY THE LOCATION
AT WHICH THE MARIHUANA RESEARCHER INTENDS TO  OPERATE,  WHICH  SHALL  BE
WITHIN  THE  STATE,  AND  SHALL  NOT  ALLOW  ANY OTHER PERSON TO USE THE
LICENSE EXCEPT AS UNDER SUBDIVISION FOUR OF THIS SECTION.
  7. PARTICIPATION  BY  CERTIFIED  PATIENTS  IN  ANY  MEDICAL  MARIHUANA
RESEARCH PROGRAM SHALL BE VOLUNTARY.
  8.  THE APPLICATION FEE FOR A MEDICAL MARIHUANA RESEARCH LICENSE SHALL
BE DETERMINED BY THE COMMISSIONER ON AN ANNUAL BASIS.
  9. EACH MEDICAL MARIHUANA RESEARCH  LICENSEE  SHALL  ISSUE  AN  ANNUAL
REPORT  TO  THE  COMMISSIONER. THE COMMISSIONER SHALL REVIEW SUCH REPORT
AND MAKE A DETERMINATION AS TO WHETHER THE RESEARCH PROJECT CONTINUES TO
MEET THE RESEARCH QUALIFICATIONS UNDER THIS SECTION.
  § 7. The public health law is amended by adding a new  section  3364-b
to read as follows:
  §  3364-B.  REGISTRATION  OF  DESIGNATED CAREGIVER FACILITIES.   1. TO
OBTAIN, AMEND OR RENEW A REGISTRATION AS A DESIGNATED CAREGIVER  FACILI-
TY,  THE  FACILITY  SHALL FILE AN APPLICATION WITH THE COMMISSIONER. THE
APPLICATION SHALL INCLUDE:
  (A) THE FACILITY'S FULL NAME AND ADDRESS;
  (B) OPERATING CERTIFICATE OR LICENSE NUMBER WHERE APPROPRIATE;
  (C) NAME, TITLE, AND SIGNATURE OF  AN  AUTHORIZED  FACILITY  REPRESEN-
TATIVE;
  (D)  A  STATEMENT THAT THE FACILITY AGREES TO SECURE AND ENSURE PROPER
HANDLING OF ALL MEDICAL MARIHUANA PRODUCTS;

S. 5657                             8

  (E) AN ACKNOWLEDGEMENT THAT A FALSE STATEMENT IN  THE  APPLICATION  IS
PUNISHABLE UNDER SECTION 210.45 OF THE PENAL LAW; AND
  (F) ANY OTHER INFORMATION THAT MAY BE REQUIRED BY THE COMMISSIONER.
  2. PRIOR TO ISSUING OR RENEWING A DESIGNATED CAREGIVER FACILITY REGIS-
TRATION,  THE  COMMISSIONER  MAY VERIFY THE INFORMATION SUBMITTED BY THE
APPLICANT.  THE APPLICANT SHALL PROVIDE, AT THE COMMISSIONER'S  REQUEST,
SUCH  INFORMATION  AND DOCUMENTATION, INCLUDING ANY CONSENTS OR AUTHORI-
ZATIONS, THAT MAY BE NECESSARY FOR THE COMMISSIONER TO VERIFY THE INFOR-
MATION.
  3. THE APPLICATION SHALL BE APPROVED, DENIED OR DETERMINED  INCOMPLETE
OR  INACCURATE  BY THE COMMISSIONER WITHIN THIRTY DAYS OF RECEIPT OF THE
APPLICATION. IF THE APPLICATION  IS  APPROVED,  THE  COMMISSIONER  SHALL
ISSUE A REGISTRATION AS SOON AS IS REASONABLY PRACTICABLE.
  4.  REGISTRATIONS  UNDER THIS SECTION SHALL REMAIN VALID FOR TWO YEARS
FROM THE DATE OF ISSUANCE.
  § 8. The public health law is amended by adding a new  section  3364-c
to read as follows:
  §  3364-C.  LABORATORY PERMITS.  1. THE COMMISSIONER SHALL APPROVE AND
PERMIT ONE OR MORE INDEPENDENT LABORATORIES TO TEST  MEDICAL  MARIHUANA.
TO BE PERMITTED AS AN INDEPENDENT LABORATORY UNDER THIS SECTION, A LABO-
RATORY  MUST  APPLY TO THE DEPARTMENT IN A FORM AND MANNER PRESCRIBED BY
THE COMMISSIONER AND MUST DEMONSTRATE THE FOLLOWING TO THE  SATISFACTION
OF THE COMMISSIONER:
  (A) THE OWNERS AND DIRECTORS OF THE LABORATORY ARE OF GOOD MORAL CHAR-
ACTER;
  (B)  THE  LABORATORY  AND  ITS  STAFF  HAVE THE SKILLS, RESOURCES, AND
EXPERTISE NEEDED TO ACCURATELY  AND  CONSISTENTLY  PERFORM  ALL  TESTING
REQUIRED;
  (C)  THE  LABORATORY HAS IN PLACE AND WILL MAINTAIN ADEQUATE POLICIES,
PROCEDURES, AND FACILITY SECURITY TO ENSURE PROPER COLLECTION, LABELING,
ACCESSIONING, PREPARATION, ANALYSIS,  RESULT  REPORTING,  DISPOSAL,  AND
STORAGE OF MEDICAL MARIHUANA;
  (D) THE LABORATORY IS PHYSICALLY LOCATED IN NEW YORK STATE;
  (E)  THE  LABORATORY HAS A CERTIFICATE OF APPROVAL AS AN ENVIRONMENTAL
LABORATORY ISSUED BY THE COMMISSIONER UNDER TITLE ONE OF ARTICLE FIVE OF
THIS CHAPTER; AND
  (F) THE LABORATORY MEETS ALL REQUIREMENTS PRESCRIBED BY  THIS  CHAPTER
AND THE COMMISSIONER IN REGULATION.
  2. THE OWNER OF AN INDEPENDENT LABORATORY PERMITTED UNDER THIS SECTION
SHALL NOT HOLD A REGISTRATION AS A REGISTERED ORGANIZATION AND SHALL NOT
HAVE ANY DIRECT OR INDIRECT OWNERSHIP INTEREST IN SUCH REGISTERED ORGAN-
IZATION.  NO BOARD MEMBER, MANAGER, OWNER, PARTNER, PRINCIPAL STAKEHOLD-
ER,  OR  MEMBER OF A REGISTERED ORGANIZATION, OR SUCH PERSON'S IMMEDIATE
FAMILY, SHALL HAVE AN INTEREST OR VOTING RIGHTS IN ANY INDEPENDENT LABO-
RATORY PERMITTEE. NO REGISTERED ORGANIZATION SHALL HAVE  ANY  DIRECT  OR
INDIRECT OWNERSHIP INTEREST IN SUCH LABORATORY.
  3.  AN  INDEPENDENT LABORATORY SHALL NOT BE REQUIRED TO BE LICENSED BY
THE FEDERAL DRUG ENFORCEMENT ADMINISTRATION.
  § 9. Subdivision 9 of section 3365 of the public health law, as  added
by chapter 90 of the laws of 2014, is amended to read as follows:
  9.  [The  commissioner  shall register no more than five] A registered
[organizations] ORGANIZATION  that  [manufacture]  MANUFACTURES  medical
marihuana  [with]  MAY  HAVE  no more than [four] EIGHT dispensing sites
wholly owned and operated by [such]  THE  registered  organization.  The
commissioner  shall  ensure  that  such  [registered  organizations and]
dispensing sites are geographically distributed across  the  state.  The

S. 5657                             9

commission  [may]  SHALL  register  additional  registered organizations
REFLECTING THE DEMOGRAPHICS OF THE STATE.
  §  10.  Subdivision  1  of section 3365-a of the public health law, as
added by chapter 416 of the laws of 2015, is amended to read as follows:
  1. There is hereby established in the department an emergency  medical
marihuana  access program (referred to in this section as the "program")
under this section. The purpose of the program is to expedite the avail-
ability of medical marihuana to avoid suffering and loss of life, during
the period before full  implementation  of  and  production  under  this
title,  especially  in the case of patients whose [serious] condition is
progressive and degenerative or is such  that  delay  in  the  patient's
medical  use  of marihuana poses a serious risk to the patient's life or
health. The commissioner shall implement the program as expeditiously as
practicable, including by emergency regulation.
  § 11. Subdivision 1 of section 3369 of the public health law, as added
by chapter 90 of the laws of 2014, is amended to read as follows:
  1. Certified patients,  designated  caregivers,  DESIGNATED  CAREGIVER
FACILITIES,  DESIGNATED  CAREGIVER FACILITY EMPLOYEES, MEDICAL MARIHUANA
RESEARCH PROGRAM EMPLOYEES, practitioners, registered organizations  and
the  employees  of  registered  organizations  shall  not  be subject to
arrest, prosecution, or penalty in any manner, or denied  any  right  or
privilege,  including  but  not limited to civil penalty or disciplinary
action by a business or occupational or professional licensing board  or
bureau,  solely for the certified medical use or manufacture of marihua-
na, or for any other action or conduct in accordance with this title.
  § 12. Section 3369-d of the public health law, as added by chapter  90
of the laws of 2014, is amended to read as follows:
  § 3369-d. Pricing. [1. Every sale of medical marihuana shall be at the
price  determined by the commissioner. Every charge made or demanded for
medical marihuana not in accordance with the  price  determined  by  the
commissioner, is prohibited.
  2.  The commissioner is hereby authorized to set the per dose price of
each form of medical marihuana sold by any registered  organization.  In
setting  the  per  dose  price  of  each  form of medical marihuana, the
commissioner shall consider the fixed and variable  costs  of  producing
the  form  of marihuana and any other factor the commissioner, in his or
her discretion, deems relevant to determining the per dose price of each
form  of  medical  marihuana.]  REGISTERED  ORGANIZATIONS  SHALL  SUBMIT
DOCUMENTATION  OF ANY PRICE AND CHANGE IN PRICE PER DOSE FOR ANY MEDICAL
MARIHUANA PRODUCT TO THE COMMISSIONER WITHIN FIFTEEN DAYS OF SETTING  OR
CHANGING  THE  PRICE.  PRIOR  APPROVAL  BY THE COMMISSIONER SHALL NOT BE
REQUIRED FOR ANY PRICE OR CHANGE OF PRICE. HOWEVER, THE COMMISSIONER  IS
AUTHORIZED  TO MODIFY THE PRICE PER DOSE FOR ANY MEDICAL MARIHUANA PROD-
UCT IF NECESSARY TO MAINTAIN PUBLIC ACCESS TO APPROPRIATE MEDICATION.
  § 13. This act shall take effect immediately; provided, however,  that
the  amendments to title 5-A of article 33 of the public health law made
by sections one, two, three, four, five, six, seven, eight,  nine,  ten,
eleven  and twelve of this act shall not affect the repeal of such title
and shall be deemed repealed therewith. Effective immediately, the addi-
tion, amendment and/or repeal of any rule or  regulation  necessary  for
the   implementation of this act on its effective date are authorized to
be made and completed on or before such effective date.

S5657A - Details

Current Committee:: Senate Finance
Law Section:: Public Health Law
Laws Affected:: Amd Pub Health L, generally

S5657A - Summary

S5657A - Sponsor Memo

 
BILL NUMBER: S5657A

SPONSOR: SAVINO
 
TITLE OF BILL:

An act to amend the public health law, in relation to medical marihuana

 
PURPOSE OR GENERAL IDEA OF BILL:

THIS BILL ADDRESSES SEVERAL PROBLEMS WITH THE MEDICAL MARIJUANA PROGRAM.
THIS BILL CONSOLIDATES SEVERAL PROPOSALS FROM OTHER BILLS, AS WELL AS
CHANGES TO THE MEDICAL PROGRAM PROPOSED IN THE 2019 EXECUTIVE BUDGET'S
CANNABIS REGULATION AND TAXATION ACT (CRTA).

 
SUMMARY OF SPECIFIC PROVISIONS:

Section 1: Amends PHL § 3360 to:

* Expand eligible conditions to include any condition certified by the
practitioner;

* Allow any practitioner otherwise authorized to prescribe controlled
substances to certify patients for medical marijuana;

* Remove prohibitions on the smoking of medical marijuana; and

* Create the categories of "designated caregiver facility," "designated
caregiver facility employee," and "medical marihuana research program."

Section 2: Amends PHI § 3361 to make conforming changes.

Section 3: Amends PHL § 3362 to:

* Change possession limits from a 30 day to a 60 day supply;

* Authorize possession, acquisition, delivery, transfer, and adminis-
tration of medical marijuana by designated caregiver facilities and
their employees subject to certain requirements; and * Prohibit smoking
of medical marijuana in any place where tobacco may not be smoked under
the Clean Indoor Air Act.

Section 4: Amends PHL § 3363 to:

* Remove the $50 patient application fee for registry ID cards;

* Remove patient-per-caregiver limits when the caregiver is a designated
caregiver facility; and

* Make conforming changes Section 5: Amends PHL . 3364 to:

* Authorize registered organizations (ROs) to contract out ancillary
functions such as shipping, construction, and security; and

* Make conforming changes

Section 6: Creates a new PHL § 3364-a, "medical marihuana research
licenses," to:


* Establish a medical marijuana research license for purposes of test-
ing, clinical investigations, and safety and efficacy or genomic or
agricultural research relating to medical marijuana; and *Details appli-
cation, licensing, and oversight process.

Section 7: Creates a new PHL § 3364-b, "registration of designated care-
giver facilities," to:

* Establishes registration process for "designated caregiver facilities"
among provider types defined in section 1 of the bill; and

* Details application, registration, and oversight process. Section 8:
Creates a new PHL § 3364-c, "laboratory permits," to:

* Detail application, permitting, and oversight process. Section 9:
Amends PHL § 3365 to:

* Increase dispensaries per RO from 4 to 8; and

* Direct the Commissioner to register additional ROs reflecting the
demographics of the state. Section 10: Amends PHL § 3365-a to make
conforming changes. Section 11: Amends PHL § 3369 to make conforming
changes.

Section 12: Amends PHL § 3369-d to remove prior approval of medical
marijuana prices; maintain requirement for ROs to document price chang-
es; and maintain the commissioner's power to modify prices if necessary
to maintain access.

Section 13: Effective date.

 
JUSTIFICATION:

Open conditions list: There is no pharmaceutical other than medical
marijuana for which the State restricts its use to a limited list of
conditions. Setting a conditions list in statute takes medical decisions
out of the hands of the practitioners who know their patients best and
whose judgment the law respects for much more dangerous drugs. Practi-
tioners also lack clarity about which conditions are actually covered.
For example, the Public Health Law definition of "severe or chronic
pain" is inconsistent with regulatory language for "severe debilitating
pain that degrades health and functional capability."

This bill would maintain the naming of several conditions in statute for
illustrative purposes, including some added in the Governor's 2019
Cannabis Regulation and Taxation Act (CRTA), but also allows "any other
condition certified by the practitioner." While the d rafting is differ-
ent, the effect is the same as S2058 of 2019.

Expanded practitioner list: Today, physicians, physician assistants, and
nurse practitioners can certify patients. However, there are other cate-
gories of practitioner outside these who are authorized to prescribe
much more dangerous substances and often treat conditions for which a
patient may be eligible (such as podiatrists and dentists whose treat-
ments involve pain medication.) This bill expands the practitioner cate-
gories to cover these groups, similar to S2056 of 2019.


Strike patient registry fees; increase supply from 30 to 60 days:
Current law requires a $50 application fee for registry identification
cards and limits patients to a 30-day supply. While the application fee
is often waived, it presents a barrier to access that does not exist for
patients with any other pharmaceutical product.  Current law also limits
patients to acquiring 30-day supplies at once distances, this limits
access. The 2019 Executive budget proposed Cannabis Regulation and Taxa-
tion Act (CRTA) included both of these changes.

Allow smoking: For some patients, smoking is the most affordable deliv-
ery method and enable them to effectively limit dosage. Out of over 30
states that now have medical marijuana programs, only 4 disallow smoking
as New York does. While smoking can involve respiratory or other issues,
the quantities involved in medical marijuana use are very limited, and
should be a matter between patient and practitioner. This legislation
would protect the public by making medical marihuana smoking subject to
the Clean Indoor Air Act restrictions, similar to S490 of 2019.

Facility caregivers: Current law allows patients to designate up to two
people as caregivers under the program. Caregivers are capped at five
patients each. These caps have caused problems administering medical
marijuana in residential facilities or hospitals where there may be more
than five patients using medical marijuana for a given caregiver, or
where a patient may see more than two potential caregiver personnel
(e.g., nurses) on a regular basis. This bill authorizes, but does not
mandate, certain facilities to become "designated care giver facili-
ties," exempting them from such restrictions, similar to 52059 of 2019
and language in the CRTA.

Research licenses: While there is significant research, being done over-
seas, medical marijuana research in the United States is limited.  This
bill would facilitate medical marijuana research in New York based on
departmental regulations. Both S2059 of 2019 and the CRTA also authorize
research licenses.

Expanded lab testing: Today, the State's Wadsworth Laboratory is the
only lab authorized to test medical marijuana. As the program expands,
more lab capacity is needed. Commercial labs with Drug Enforcement Agen-
cy (DEA) licenses may be reluctant to test medical marijuana out of fear
of endangering these DEA licenses. This bill removes the requirement
that a lab which tests medical marijuana hold a DEA license and details
State permitting of labs for medical marijuana testing, similar to both
S2059 of 2019 and the CRTA.

RO contracting: Registered organizations (R0s) are currently not allowed
to contract out any part of the production and distribution processes.
This is contrary to standard business practice, is inefficient and rais-
es costs. This bill allows ROs to contract out ancillary functions, such
as security or transportation, while ensuring that laws applicable to
the RO for the purpose of those services would apply to the contractors
as well and excluding certain service s directly related to the manufac-
turing process (such as trimming).  This is similar to both 52059 of
2019 and the CRTA.

Increased dispensaries and ROs: Current law authorizes up to four
dispensaries for each of the 10 ROs that engages in manufacturing.  This
places New York far below every other state medical marijuana programs
for dispensary access per population. For comparison, New York has
approximately 500,000 people per dispensary versus 233,000 to 1 in Illi-
nois; 192,000 in Michigan, and 70,000 in Florida. This bill would double
the number from 4 to 8 per RO. The bill also directs the commissioner to
register additional ROs "reflecting the demographics of the state."
While current law does authorize the registration of additional ROs,
this explicit direction signals the importance of greater minority and
women-owned participation in the medical marijuana program. The dispen-
sary expansion is also found in S2059 of 2019.

Modifying price controls: Current law authorizes price setting by the
commissioner and prohibits any sale not in accordance with such prices.
In practice, ROs submit prices and price changes to the department for
approval. Since enactment, not one price setting or proposed change has
ever been rejected. But it takes weeks or even months for ROs to get
approvals, during which time they either cannot roll out new products or
cannot sell existing products at their new, typically lower prices
(nearly all price changes are downward changes; maintains reporting of
all price changes to the department; and maintains the commissioner's
authority to reject or modify prices if necessary to maintain access.

 
PRIOR LEGISLATIVE HISTORY:

New bill

 
FISCAL IMPLICATIONS:

Minimal. Minor reduction in patient registration fees ($50 each); likely
revenue increase from licensing of additional ROs and fees associated
with new license categories.

 
EFFECTIVE DATE:
Immediate.

S5657A - Bill Text download pdf


                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                 5657--A

                       2019-2020 Regular Sessions

                            I N  S E N A T E

                              May 10, 2019
                               ___________

Introduced  by  Sen.  SAVINO -- read twice and ordered printed, and when
  printed to be committed  to  the  Committee  on  Health  --  committee
  discharged, bill amended, ordered reprinted as amended and recommitted
  to said committee

AN ACT to amend the public health law, in relation to medical marihuana

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. Subdivisions 1, 5, 7 and 12 of section 3360 of  the  public
health  law,  subdivisions  1, 5, 7 and 12 as added by chapter 90 of the
laws of 2014, paragraph (a) of subdivision 7 as amended by  chapter  273
of the laws of 2018, are amended and three new subdivisions 5-a, 5-b and
19 are added to read as follows:
  1. "Certified medical use" means the acquisition, possession, use, or,
transportation  of  medical  marihuana  by  a  certified patient, or the
acquisition, possession, delivery, transportation or  administration  of
medical  marihuana  by  a  designated  caregiver, for use as part of the
treatment of the patient's  [serious]  condition,  as  authorized  in  a
certification  under this title including enabling the patient to toler-
ate treatment for the [serious] condition. [A certified medical use does
not include smoking.]
  5. "Designated caregiver" means the individual OR  CAREGIVER  FACILITY
designated by a certified patient in a registry application. A certified
patient  may  designate  up to two designated caregivers, NOT COUNTING A
DESIGNATED CAREGIVER FACILITY OR DESIGNATED CAREGIVER FACILITY EMPLOYEE.
  5-A. "DESIGNATED CAREGIVER FACILITY" MEANS AN  ENTITY  THAT  REGISTERS
WITH  THE COMMISSIONER TO ASSIST ONE OR MORE CERTIFIED PATIENTS WITH THE
ACQUISITION, POSSESSION, DELIVERY, TRANSPORTATION OR  ADMINISTRATION  OF
MEDICAL  MARIHUANA AND IS: A GENERAL HOSPITAL OR RESIDENTIAL HEALTH CARE
FACILITY OPERATING UNDER ARTICLE TWENTY-EIGHT OF THIS CHAPTER; AN  ADULT
CARE  FACILITY  OPERATING UNDER TITLE TWO OF ARTICLE SEVEN OF THE SOCIAL
SERVICES LAW; A COMMUNITY  MENTAL  HEALTH  RESIDENCE  ESTABLISHED  UNDER
SECTION  41.44  OF  THE  MENTAL  HYGIENE LAW; A HOSPITAL OPERATING UNDER
SECTION 7.17 OF THE MENTAL HYGIENE LAW; A MENTAL HYGIENE FACILITY  OPER-
ATING  UNDER  ARTICLE THIRTY-ONE OF THE MENTAL HYGIENE LAW; AN INPATIENT

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD11129-05-9

S. 5657--A                          2

OR RESIDENTIAL TREATMENT PROGRAM CERTIFIED UNDER ARTICLE  THIRTY-TWO  OF
THE  MENTAL  HYGIENE LAW; A RESIDENTIAL FACILITY FOR THE CARE AND TREAT-
MENT OF PERSONS WITH DEVELOPMENTAL DISABILITIES OPERATING UNDER  ARTICLE
SIXTEEN  OF THE MENTAL HYGIENE LAW; A RESIDENTIAL TREATMENT FACILITY FOR
CHILDREN AND YOUTH OPERATING UNDER  ARTICLE  THIRTY-ONE  OF  THE  MENTAL
HYGIENE  LAW;  A  PUBLIC  SCHOOL  OR  PRIVATE SCHOOL OPERATING UNDER THE
EDUCATION LAW; A RESEARCH INSTITUTION WITH AN INTERNAL REVIEW  BOARD;  A
MEDICAL  MARIHUANA  RESEARCH PROGRAM LICENSED UNDER SECTION THIRTY-THREE
HUNDRED SIXTY-FOUR-A OF THIS TITLE; OR ANY OTHER FACILITY AS  DETERMINED
BY THE COMMISSIONER IN REGULATION.
  5-B.  "DESIGNATED  CAREGIVER FACILITY EMPLOYEE" MEANS AN EMPLOYEE OF A
DESIGNATED CAREGIVER FACILITY.
  7. (a) ["Serious condition"] "CONDITION" means:
  (i) having one of the following [severe debilitating or life-threaten-
ing] conditions: cancer,  positive  status  for  human  immunodeficiency
virus or acquired immune deficiency syndrome, amyotrophic lateral scler-
osis,  Parkinson's  disease,  multiple  sclerosis, damage to the nervous
tissue of the spinal cord  with  objective  neurological  indication  of
intractable  spasticity,  epilepsy, inflammatory bowel disease, neuropa-
thies, Huntington's disease, post-traumatic stress disorder,  pain  that
degrades health and functional capability where the use of medical mari-
huana   is  an  alternative  to  opioid  use,  substance  use  disorder,
ALZHEIMER'S, MUSCULAR DYSTROPHY, DYSTONIA, RHEUMATOID ARTHRITIS, AUTISM,
or [as added by the commissioner; and
  (ii) any of the following conditions where it is clinically associated
with, or a complication of, a condition  under  this  paragraph  or  its
treatment:  cachexia or wasting syndrome; severe or chronic pain; severe
nausea; seizures; severe or persistent muscle spasms; or such conditions
as are added by the commissioner.
  (b) No later than eighteen months from  the  effective  date  of  this
section,  the  commissioner shall determine whether to add the following
serious conditions: Alzheimer's,  muscular  dystrophy,  dystonia,  post-
traumatic  stress disorder and rheumatoid arthritis] ANY OTHER CONDITION
CERTIFIED BY THE PRACTITIONER.
  12. "Practitioner" means  a  practitioner  who  (i)  [is  a  physician
licensed  by New York state and practicing within the state,] IS AUTHOR-
IZED TO PRESCRIBE CONTROLLED SUBSTANCES WITHIN THE STATE; (ii) [who]  by
training  or  experience  is qualified to treat a [serious] condition as
defined in subdivision seven of this section; and (iii) [has completed a
two to four hour course as determined by the commissioner in  regulation
and  registered  with  the  department; provided however, a registration
shall not be denied without cause. Such course may  count  toward  board
certification  requirements.  The commissioner shall consider the inclu-
sion of nurse practitioners under this title based  upon  considerations
including  access and availability. After such consideration the commis-
sioner is authorized to deem nurse practitioners as practitioners  under
this  title] COMPLETES, AT A MINIMUM, A TWO HOUR COURSE AS DETERMINED BY
THE COMMISSIONER. A PERSON'S STATUS AS A PRACTITIONER UNDER  THIS  TITLE
IS DEEMED TO BE A "LICENSE" FOR PURPOSES OF SECTION THIRTY-THREE HUNDRED
NINETY OF THIS ARTICLE.
  19.  "MEDICAL  MARIHUANA  RESEARCH  PROGRAM" MEANS A MEDICAL MARIHUANA
RESEARCH   PROGRAM   LICENSED   UNDER   SECTION   THIRTY-THREE   HUNDRED
SIXTY-FOUR-A OF THIS TITLE.
  §  2.  Subdivisions  1,  2, and 9 of section 3361 of the public health
law, subdivisions 1 and 2 as added by chapter 90 of the laws of 2014 and

S. 5657--A                          3

subdivision 9 as added by chapter 416 of the laws of 2015,  are  amended
to read as follows:
  1.  A  patient certification may only be issued if: (a) a practitioner
has been registered with the department  to  issue  a  certification  as
determined  by  the commissioner; (b) the patient has a [serious] condi-
tion, which shall be specified in the patient's health care record;  (c)
the  practitioner  by  training  or experience is qualified to treat the
[serious] condition; (d) the patient is under the practitioner's contin-
uing care for the [serious] condition; and  (e)  in  the  practitioner's
professional opinion and review of past treatments, the patient is like-
ly  to  receive  therapeutic  or  palliative benefit from the primary or
adjunctive treatment with medical use of  marihuana  for  the  [serious]
condition.
  2.  The  certification  shall  include (a) the name, date of birth and
address of the patient; (b) a statement that the patient has a [serious]
condition and the patient is  under  the  practitioner's  care  for  the
[serious]  condition; (c) a statement attesting that all requirements of
subdivision one of this section have been satisfied; (d) the  date;  and
(e)  the  name,  address, federal registration number, telephone number,
and the  handwritten  signature  of  the  certifying  practitioner.  The
commissioner  may  require by regulation that the certification shall be
on a form provided by the department. The practitioner may state in  the
certification  that,  in  the  practitioner's  professional opinion, the
patient would benefit from medical  marihuana  only  until  a  specified
date. The practitioner may state in the certification that, in the prac-
titioner's  professional opinion, the patient is terminally ill and that
the certification shall not expire until the patient dies.
  9.(a) A certification may be a special certification if,  in  addition
to  the  other requirements for a certification, the practitioner certi-
fies in the certification that  the  patient's  [serious]  condition  is
progressive  and  degenerative  or that delay in the patient's certified
medical use of marihuana poses a serious risk to the patient's  life  or
health.
  (b)  The  department  shall  create  the form to be used for a special
certification and shall make that form available to be  downloaded  from
the department's website.
  § 3. Subdivisions 1 and 2 of section 3362 of the public health law, as
added  by chapter 90 of the laws of 2014, are amended and a new subdivi-
sion 3 is added to read as follows:
  1. The possession, acquisition, use, delivery,  transfer,  transporta-
tion,  or  administration of medical marihuana by a certified patient or
designated caregiver possessing a valid  registry  identification  card,
for  certified  medical  use, shall be lawful under this title; provided
that:
  (a) the marihuana that may be possessed by a certified  patient  shall
not  exceed  a  [thirty] SIXTY day supply of the dosage as determined by
the practitioner, consistent with any guidance and regulations issued by
the commissioner, provided that during the last seven days of any [thir-
ty] SIXTY day period, the certified patient may also possess up to  such
amount for the next [thirty] SIXTY day period;
  (b)  the marihuana that may be possessed by designated caregivers does
not exceed the quantities referred to in paragraph (a) of this  subdivi-
sion for each certified patient for whom the caregiver possesses a valid
registry identification card, up to five certified patients;
  (c) THE MARIHUANA THAT MAY BE POSSESSED BY DESIGNATED CAREGIVER FACIL-
ITIES  DOES  NOT  EXCEED  THE QUANTITIES REFERRED TO IN PARAGRAPH (A) OF

S. 5657--A                          4

THIS SUBDIVISION FOR EACH CERTIFIED PATIENT UNDER CARE OR  TREATMENT  OF
THE FACILITY;
  (D)  the  form  or forms of medical marihuana that may be possessed by
the certified patient [or], designated caregiver, OR DESIGNATED CAREGIV-
ER FACILITY pursuant to a certification shall be in compliance with  any
recommendation or limitation by the practitioner as to the form or forms
of  medical marihuana or dosage for the certified patient in the certif-
ication; and
  [(d)] (E) the medical marihuana shall be kept in the original  package
in  which  it  was dispensed under subdivision twelve of section thirty-
three hundred sixty-four of this title, except for the  portion  removed
for  immediate  consumption  for  certified medical use by the certified
patient.
  2. Notwithstanding subdivision one of this section:
  (a) possession of medical marihuana shall not  be  lawful  under  this
title  if it is smoked, consumed, vaporized, or grown in a public place,
regardless of the form of medical  marihuana  stated  in  the  patient's
certification.
  (b)  a  [person]  CERTIFIED PATIENT OR DESIGNATED CAREGIVER possessing
medical marihuana under this title shall possess  his  or  her  registry
identification card at all times when in immediate possession of medical
marihuana.
  (C) MEDICAL MARIHUANA MAY NOT BE SMOKED IN ANY PLACE WHERE TOBACCO MAY
NOT  BE  SMOKED  UNDER ARTICLE THIRTEEN-E OF THIS CHAPTER, REGARDLESS OF
THE FORM OF MEDICAL MARIHUANA STATED IN THE PATIENT'S CERTIFICATION.
  3. THE POSSESSION, ACQUISITION, DELIVERY, TRANSFER, TRANSPORTATION, OR
ADMINISTRATION OF MEDICAL MARIHUANA BY A DESIGNATED  CAREGIVER  FACILITY
OR  DESIGNATED  CAREGIVER  FACILITY  EMPLOYEE SHALL BE LAWFUL UNDER THIS
TITLE PROVIDED THAT:
  (A) THE DESIGNATED CAREGIVER FACILITY REGISTERS WITH THE DEPARTMENT ON
A FORM PROVIDED BY THE COMMISSIONER;
  (B) SUCH POSSESSION, ACQUISITION, DELIVERY, TRANSFER,  TRANSPORTATION,
OR  ADMINISTRATION  IS  ON  BEHALF  OF  A CERTIFIED PATIENT POSSESSING A
REGISTRY IDENTIFICATION CARD;
  (C) THE DESIGNATED CAREGIVER FACILITY MAINTAINS A COPY OF THE REGISTRY
IDENTIFICATION CARD OF EACH CERTIFIED PATIENT FOR  WHICH  IT  POSSESSES,
ACQUIRES,  DELIVERS, TRANSFERS, TRANSPORTS, OR ADMINISTERS MEDICAL MARI-
HUANA; AND
  (D) A DESIGNATED CAREGIVER FACILITY EMPLOYEE SHALL BE IDENTIFIED AS AN
EMPLOYEE WHEN NECESSARY, AS PROVIDED BY THE COMMISSIONER.
  § 4. Subdivisions 2, 3, 5, and 11 of section 3363 of the public health
law, as added by chapter 90 of the laws of 2014, are amended to read  as
follows:
  2.  To obtain, amend or renew a registry identification card, a certi-
fied patient or designated caregiver shall file a  registry  application
with  the  department.  The  registry application or renewal application
shall include:
  (a) in the case of a certified patient:
  (i) the patient's certification (a new written certification shall  be
provided with a renewal application);
  (ii) the name, address, and date of birth of the patient;
  (iii) the date of the certification;
  (iv)  if  the  patient  has  a registry identification card based on a
current valid certification,  the  registry  identification  number  and
expiration date of that registry identification card;

S. 5657--A                          5

  (v)  the  specified  date  until  which the patient would benefit from
medical marihuana, if the certification states such a date;
  (vi)  the  name,  address,  federal registration number, and telephone
number of the certifying practitioner;
  (vii) any recommendation or limitation by the practitioner as  to  the
form  or forms of medical marihuana or dosage for the certified patient;
and
  (viii)  other  individual  identifying  information  required  by  the
department;
  (b)  (I) in the case of a certified patient, if the patient designates
a designated caregiver, the name, address, and  date  of  birth  of  the
designated  caregiver,  and  other  individual  identifying  information
required by the department;
  (II) IF THE DESIGNATED  CAREGIVER  IS  A  MEDICAL  MARIHUANA  RESEARCH
PROGRAM,  THE  NAME  OF  THE  ORGANIZATION  CONDUCTING THE RESEARCH; THE
ADDRESS, PHONE NUMBER, AND NAME OF THE INDIVIDUAL LEADING  THE  RESEARCH
OR  APPROPRIATE  DESIGNEE; AND OTHER IDENTIFYING INFORMATION REQUIRED BY
THE DEPARTMENT;
  (c) in the case of a designated caregiver:
  (i) the name, address, and date of birth of the designated caregiver;
  (ii) if the designated caregiver has a registry  identification  card,
the  registry identification number and expiration date of that registry
identification card; and
  (iii) other individual identifying information required by the depart-
ment;
  (d) a statement that a false statement  made  in  the  application  is
punishable under section 210.45 of the penal law;
  (e)  the  date  of  the application and the signature of the certified
patient or designated caregiver, as the case may be; AND
  (f) [a fifty dollar application fee, provided, that the department may
waive or reduce the fee in cases of financial hardship; and
  (g)] any other requirements determined by the commissioner.
  3. Where a certified patient is under the age of eighteen:
  (a) The application for a registry identification card shall  be  made
by  an  appropriate person over twenty-one years of age. The application
shall state facts demonstrating that the person is appropriate.
  (b) The designated caregiver shall be (i) a parent or  legal  guardian
of  the certified patient, (ii) a person designated by a parent or legal
guardian, [or] (iii) IN THE CASE OF SUCH A CERTIFIED PATIENT BEING CARED
FOR BY A DESIGNATED CAREGIVER FACILITY, THE DESIGNATED CAREGIVER FACILI-
TY DESIGNATED BY THE PARENT OR LEGAL GUARDIAN; OR  (IV)  an  appropriate
person  approved  by  the  department  upon a sufficient showing that no
parent or legal guardian is appropriate or available.
  5. No person may be a designated caregiver for more than  five  certi-
fied  patients  at one time; PROVIDED HOWEVER THAT THIS LIMITATION SHALL
NOT APPLY TO A DESIGNATED CAREGIVER  FACILITY  OR  DESIGNATED  CAREGIVER
FACILITY EMPLOYEE.
  11.  A certified patient or designated caregiver who has been issued a
registry identification card shall notify the department of  any  change
in  his or her name or address or, with respect to the patient, if he or
she ceases to have the [serious] condition noted  on  the  certification
within  ten  days  of such change. The certified patient's or designated
caregiver's registry identification card shall  be  deemed  invalid  and
shall be returned promptly to the department.

S. 5657--A                          6

  § 5. Subdivisions 3 and 5 of section 3364 of the public health law, as
added  by chapter 90 of the laws of 2014, are amended and a new subdivi-
sion 14 is added to read as follows:
  3.  Each  registered  organization  shall contract with an independent
laboratory PERMITTED UNDER SECTION THIRTY-THREE HUNDRED SIXTY-FOUR-C  OF
THIS  TITLE  to  test  the  medical marihuana produced by the registered
organization. The commissioner shall approve the laboratory and  require
that the laboratory report testing results in a manner determined by the
commissioner. The commissioner is authorized to issue regulation requir-
ing the laboratory to perform certain tests and services.
  5.  (a)  No  registered  organization may sell, deliver, distribute or
dispense to any certified patient or designated caregiver a quantity  of
medical  marihuana  larger  than  that  individual  would  be allowed to
possess under this title.
  (b) When dispensing medical marihuana to a certified patient or desig-
nated caregiver, the registered organization (i) shall not  dispense  an
amount  greater  than a [thirty] SIXTY day supply to a certified patient
until the certified patient has exhausted all but  a  seven  day  supply
provided  pursuant  to a previously issued certification, and (ii) shall
verify the information in subparagraph (i) of this paragraph by consult-
ing the prescription monitoring program registry under  section  thirty-
three hundred forty-three-a of this article.
  (c)  Medical  marihuana dispensed to a certified patient or designated
caregiver by a registered organization shall conform to any  recommenda-
tion  or  limitation  by  the  practitioner  as  to the form or forms of
medical marihuana or dosage for the certified patient.
  14. A REGISTERED ORGANIZATION MAY CONTRACT WITH A PERSON OR ENTITY  TO
PROVIDE  FACILITIES,  EQUIPMENT  OR  SERVICES  THAT ARE ANCILLARY TO THE
REGISTERED ORGANIZATION'S FUNCTIONS OR  ACTIVITIES  UNDER  THIS  SECTION
(INCLUDING,  BUT  NOT  LIMITED  TO, SHIPPING, MAINTENANCE, CONSTRUCTION,
REPAIR, AND SECURITY),  BUT  NOT  INCLUDING  ANY  FUNCTION  OR  ACTIVITY
DIRECTLY  INVOLVING THE PLANTING, GROWING, TENDING, HARVESTING, PROCESS-
ING, OR PACKAGING OF PLANTS; OR ANY OTHER  FUNCTION  DIRECTLY  INVOLVING
MANUFACTURING  OR  RETAILING  OF  MEDICAL  MARIHUANA. ALL LAWS AND REGU-
LATIONS APPLICABLE TO SUCH  FACILITIES,  EQUIPMENT,  OR  SERVICES  SHALL
APPLY  TO THE CONTRACT. THE REGISTERED ORGANIZATION AND OTHER PARTIES TO
THE CONTRACT SHALL EACH BE RESPONSIBLE FOR COMPLIANCE WITH SUCH LAWS AND
REGULATIONS UNDER THE CONTRACT. THE COMMISSIONER  MAY  MAKE  REGULATIONS
CONSISTENT  WITH  THIS  TITLE  RELATING  TO  CONTRACTS  AND  PARTIES  TO
CONTRACTS UNDER THIS SUBDIVISION.
  § 6. The public health law is amended by adding a new  section  3364-a
to read as follows:
  §  3364-A.  MEDICAL  MARIHUANA RESEARCH LICENSES.  1. THE COMMISSIONER
SHALL ESTABLISH A MEDICAL MARIHUANA  RESEARCH  LICENSE  THAT  PERMITS  A
LICENSEE  TO  PRODUCE,  PROCESS,  PURCHASE,  POSSESS, TRANSFER, AND SELL
MARIHUANA, SUBJECT TO THIS SECTION, FOR THE FOLLOWING  LIMITED  RESEARCH
PURPOSES:
  (A) TO TEST CHEMICAL POTENCY AND COMPOSITION LEVELS;
  (B) TO CONDUCT CLINICAL INVESTIGATIONS OF MARIHUANA-DERIVED PRODUCTS;
  (C)  TO  CONDUCT  RESEARCH ON THE EFFICACY AND SAFETY OF ADMINISTERING
MARIHUANA AS PART OF MEDICAL TREATMENT; OR
  (D) TO CONDUCT GENOMIC OR AGRICULTURAL RESEARCH  RELATING  TO  MEDICAL
MARIHUANA.
  2. AS PART OF THE APPLICATION PROCESS FOR A MEDICAL MARIHUANA RESEARCH
LICENSE,  AN  APPLICANT MUST SUBMIT TO THE COMMISSIONER A DESCRIPTION OF
THE RESEARCH THAT IS INTENDED TO BE CONDUCTED AS WELL AS THE  AMOUNT  OF

S. 5657--A                          7

MARIHUANA  TO  BE  GROWN  OR PURCHASED. THE COMMISSIONER SHALL REVIEW AN
APPLICANT'S RESEARCH PROJECT AND DETERMINE WHETHER IT MEETS THE REQUIRE-
MENTS OF SUBDIVISION ONE OF THIS SECTION. IN ADDITION, THE  COMMISSIONER
SHALL ASSESS THE APPLICATION BASED ON THE FOLLOWING CRITERIA:
  (A) PROJECT QUALITY, STUDY DESIGN, VALUE, AND IMPACT;
  (B)  WHETHER  THE  APPLICANT HAS THE APPROPRIATE PERSONNEL, EXPERTISE,
FACILITIES AND INFRASTRUCTURE,  FUNDING,  AND  (TO  THE  EXTENT  LEGALLY
AVAILABLE)  APPROVALS  RELATING TO HUMAN OR ANIMAL RESEARCH, IN PLACE TO
SUCCESSFULLY CONDUCT THE PROJECT; AND
  (C) WHETHER THE AMOUNT OF MARIHUANA TO BE GROWN OR  PURCHASED  BY  THE
APPLICANT IS CONSISTENT WITH THE PROJECT'S SCOPE AND GOALS.
  3.  IF THE COMMISSIONER DETERMINES THAT THE RESEARCH PROJECT MEETS THE
REQUIREMENTS OF SUBDIVISION ONE OF THIS SECTION,  THE  COMMISSIONER  MAY
APPROVE THE APPLICATION. IF NOT, THE APPLICATION SHALL BE DENIED.
  4.  A  MEDICAL  MARIHUANA  RESEARCH LICENSEE MAY ONLY SELL OR TRANSFER
MARIHUANA GROWN OR PRODUCED WITHIN ITS OPERATION TO OTHER MEDICAL  MARI-
HUANA  RESEARCH  LICENSEES,  OR OTHERWISE FOR PURPOSES OF THE LICENSEE'S
RESEARCH.
  5. IN ESTABLISHING A MEDICAL MARIHUANA RESEARCH LICENSE,  THE  COMMIS-
SIONER MAY MAKE REGULATIONS ON THE FOLLOWING:
  (A) APPLICATION REQUIREMENTS;
  (B)   LICENSE   RENEWAL  REQUIREMENTS,  INCLUDING  WHETHER  ADDITIONAL
RESEARCH PROJECTS MAY BE ADDED OR CONSIDERED;
  (C) CONDITIONS FOR LICENSE REVOCATION;
  (D) SECURITY MEASURES TO ENSURE MARIHUANA IS NOT DIVERTED TO  PURPOSES
OTHER THAN RESEARCH;
  (E)  AMOUNT  OF  PLANTS, USEABLE MARIHUANA, MARIHUANA CONCENTRATES, OR
MARIHUANA-INFUSED PRODUCTS A LICENSEE MAY HAVE ON ITS PREMISES;
  (F) LICENSEE REPORTING REQUIREMENTS;
  (G) CONDITIONS UNDER WHICH MARIHUANA GROWN BY LICENSED  MEDICAL  MARI-
HUANA  PRODUCERS AND OTHER PRODUCT TYPES FROM LICENSED MEDICAL MARIHUANA
PROCESSORS MAY BE DONATED TO MEDICAL MARIHUANA RESEARCH LICENSEES; AND
  (H) ANY ADDITIONAL REQUIREMENTS DEEMED NECESSARY BY THE COMMISSIONER.
  6. A MARIHUANA RESEARCH LICENSE ISSUED UNDER  THIS  SECTION  SHALL  BE
ISSUED  IN THE NAME OF THE APPLICANT OR APPLICANTS, SPECIFY THE LOCATION
AT WHICH THE MARIHUANA RESEARCHER INTENDS TO  OPERATE,  WHICH  SHALL  BE
WITHIN  THE  STATE,  AND  SHALL  NOT  ALLOW  ANY OTHER PERSON TO USE THE
LICENSE EXCEPT AS UNDER SUBDIVISION FOUR OF THIS SECTION.
  7. PARTICIPATION  BY  CERTIFIED  PATIENTS  IN  ANY  MEDICAL  MARIHUANA
RESEARCH PROGRAM SHALL BE VOLUNTARY.
  8.  THE APPLICATION FEE FOR A MEDICAL MARIHUANA RESEARCH LICENSE SHALL
BE DETERMINED BY THE COMMISSIONER ON AN ANNUAL BASIS.
  9. EACH MEDICAL MARIHUANA RESEARCH  LICENSEE  SHALL  ISSUE  AN  ANNUAL
REPORT  TO  THE  COMMISSIONER. THE COMMISSIONER SHALL REVIEW SUCH REPORT
AND MAKE A DETERMINATION AS TO WHETHER THE RESEARCH PROJECT CONTINUES TO
MEET THE RESEARCH QUALIFICATIONS UNDER THIS SECTION.
  § 7. The public health law is amended by adding a new  section  3364-b
to read as follows:
  §  3364-B.  REGISTRATION  OF  DESIGNATED CAREGIVER FACILITIES.   1. TO
OBTAIN, AMEND OR RENEW A REGISTRATION AS A DESIGNATED CAREGIVER  FACILI-
TY,  THE  FACILITY  SHALL FILE AN APPLICATION WITH THE COMMISSIONER. THE
APPLICATION SHALL INCLUDE:
  (A) THE FACILITY'S FULL NAME AND ADDRESS;
  (B) OPERATING CERTIFICATE OR LICENSE NUMBER WHERE APPROPRIATE;
  (C) NAME, TITLE, AND SIGNATURE OF  AN  AUTHORIZED  FACILITY  REPRESEN-
TATIVE;

S. 5657--A                          8

  (D)  A  STATEMENT THAT THE FACILITY AGREES TO SECURE AND ENSURE PROPER
HANDLING OF ALL MEDICAL MARIHUANA PRODUCTS;
  (E)  AN  ACKNOWLEDGEMENT  THAT A FALSE STATEMENT IN THE APPLICATION IS
PUNISHABLE UNDER SECTION 210.45 OF THE PENAL LAW; AND
  (F) ANY OTHER INFORMATION THAT MAY BE REQUIRED BY THE COMMISSIONER.
  2. PRIOR TO ISSUING OR RENEWING A DESIGNATED CAREGIVER FACILITY REGIS-
TRATION, THE COMMISSIONER MAY VERIFY THE INFORMATION  SUBMITTED  BY  THE
APPLICANT.   THE APPLICANT SHALL PROVIDE, AT THE COMMISSIONER'S REQUEST,
SUCH INFORMATION AND DOCUMENTATION, INCLUDING ANY CONSENTS  OR  AUTHORI-
ZATIONS, THAT MAY BE NECESSARY FOR THE COMMISSIONER TO VERIFY THE INFOR-
MATION.
  3.  THE APPLICATION SHALL BE APPROVED, DENIED OR DETERMINED INCOMPLETE
OR INACCURATE BY THE COMMISSIONER WITHIN THIRTY DAYS OF RECEIPT  OF  THE
APPLICATION.  IF  THE  APPLICATION  IS  APPROVED, THE COMMISSIONER SHALL
ISSUE A REGISTRATION AS SOON AS IS REASONABLY PRACTICABLE.
  4. REGISTRATIONS UNDER THIS SECTION SHALL REMAIN VALID FOR  TWO  YEARS
FROM THE DATE OF ISSUANCE.
  §  8.  The public health law is amended by adding a new section 3364-c
to read as follows:
  § 3364-C. LABORATORY PERMITS.  1. THE COMMISSIONER SHALL  APPROVE  AND
PERMIT  ONE  OR MORE INDEPENDENT LABORATORIES TO TEST MEDICAL MARIHUANA.
TO BE PERMITTED AS AN INDEPENDENT LABORATORY UNDER THIS SECTION, A LABO-
RATORY MUST APPLY TO THE DEPARTMENT IN A FORM AND MANNER  PRESCRIBED  BY
THE  COMMISSIONER AND MUST DEMONSTRATE THE FOLLOWING TO THE SATISFACTION
OF THE COMMISSIONER:
  (A) THE OWNERS AND DIRECTORS OF THE LABORATORY ARE OF GOOD MORAL CHAR-
ACTER;
  (B) THE LABORATORY AND ITS  STAFF  HAVE  THE  SKILLS,  RESOURCES,  AND
EXPERTISE  NEEDED  TO  ACCURATELY  AND  CONSISTENTLY PERFORM ALL TESTING
REQUIRED;
  (C) THE LABORATORY HAS IN PLACE AND WILL MAINTAIN  ADEQUATE  POLICIES,
PROCEDURES, AND FACILITY SECURITY TO ENSURE PROPER COLLECTION, LABELING,
ACCESSIONING,  PREPARATION,  ANALYSIS,  RESULT  REPORTING, DISPOSAL, AND
STORAGE OF MEDICAL MARIHUANA;
  (D) THE LABORATORY IS PHYSICALLY LOCATED IN NEW YORK STATE;
  (E) THE LABORATORY HAS A CERTIFICATE OF APPROVAL AS  AN  ENVIRONMENTAL
LABORATORY ISSUED BY THE COMMISSIONER UNDER TITLE ONE OF ARTICLE FIVE OF
THIS CHAPTER; AND
  (F)  THE  LABORATORY MEETS ALL REQUIREMENTS PRESCRIBED BY THIS CHAPTER
AND THE COMMISSIONER IN REGULATION.
  2. THE OWNER OF AN INDEPENDENT LABORATORY PERMITTED UNDER THIS SECTION
SHALL NOT HOLD A REGISTRATION AS A REGISTERED ORGANIZATION AND SHALL NOT
HAVE ANY DIRECT OR INDIRECT OWNERSHIP INTEREST IN SUCH REGISTERED ORGAN-
IZATION.  NO BOARD MEMBER, MANAGER, OWNER, PARTNER, PRINCIPAL STAKEHOLD-
ER, OR MEMBER OF A REGISTERED ORGANIZATION, OR SUCH  PERSON'S  IMMEDIATE
FAMILY, SHALL HAVE AN INTEREST OR VOTING RIGHTS IN ANY INDEPENDENT LABO-
RATORY  PERMITTEE.  NO  REGISTERED ORGANIZATION SHALL HAVE ANY DIRECT OR
INDIRECT OWNERSHIP INTEREST IN SUCH LABORATORY.
  3. AN INDEPENDENT LABORATORY SHALL NOT BE REQUIRED TO BE  LICENSED  BY
THE FEDERAL DRUG ENFORCEMENT ADMINISTRATION.
  §  9. Subdivision 9 of section 3365 of the public health law, as added
by chapter 90 of the laws of 2014, is amended to read as follows:
  9. [The commissioner shall register no more than  five]  A  registered
[organizations]  ORGANIZATION  that  [manufacture]  MANUFACTURES medical
marihuana [with] MAY HAVE no more than  [four]  EIGHT  dispensing  sites
wholly  owned  and  operated  by [such] THE registered organization. The

S. 5657--A                          9

commissioner shall  ensure  that  such  [registered  organizations  and]
dispensing  sites  are  geographically distributed across the state. The
commission [may]  SHALL  register  additional  registered  organizations
REFLECTING THE DEMOGRAPHICS OF THE STATE.
  §  10.  Subdivision  1  of section 3365-a of the public health law, as
added by chapter 416 of the laws of 2015, is amended to read as follows:
  1. There is hereby established in the department an emergency  medical
marihuana  access program (referred to in this section as the "program")
under this section. The purpose of the program is to expedite the avail-
ability of medical marihuana to avoid suffering and loss of life, during
the period before full  implementation  of  and  production  under  this
title,  especially  in the case of patients whose [serious] condition is
progressive and degenerative or is such  that  delay  in  the  patient's
medical  use  of marihuana poses a serious risk to the patient's life or
health. The commissioner shall implement the program as expeditiously as
practicable, including by emergency regulation.
  § 11. Subdivision 1 of section 3369 of the public health law, as added
by chapter 90 of the laws of 2014, is amended to read as follows:
  1. Certified patients,  designated  caregivers,  DESIGNATED  CAREGIVER
FACILITIES,  DESIGNATED  CAREGIVER FACILITY EMPLOYEES, MEDICAL MARIHUANA
RESEARCH PROGRAM EMPLOYEES, practitioners, registered organizations  and
the  employees  of  registered  organizations  shall  not  be subject to
arrest, prosecution, or penalty in any manner, or denied  any  right  or
privilege,  including  but  not limited to civil penalty or disciplinary
action by a business or occupational or professional licensing board  or
bureau,  solely for the certified medical use or manufacture of marihua-
na, or for any other action or conduct in accordance with this title.
  § 12. Section 3369-d of the public health law, as added by chapter  90
of the laws of 2014, is amended to read as follows:
  § 3369-d. Pricing. [1. Every sale of medical marihuana shall be at the
price  determined by the commissioner. Every charge made or demanded for
medical marihuana not in accordance with the  price  determined  by  the
commissioner, is prohibited.
  2.  The commissioner is hereby authorized to set the per dose price of
each form of medical marihuana sold by any registered  organization.  In
setting  the  per  dose  price  of  each  form of medical marihuana, the
commissioner shall consider the fixed and variable  costs  of  producing
the  form  of marihuana and any other factor the commissioner, in his or
her discretion, deems relevant to determining the per dose price of each
form  of  medical  marihuana.]  REGISTERED  ORGANIZATIONS  SHALL  SUBMIT
DOCUMENTATION  OF ANY PRICE AND CHANGE IN PRICE PER DOSE FOR ANY MEDICAL
MARIHUANA PRODUCT TO THE COMMISSIONER WITHIN FIFTEEN DAYS OF SETTING  OR
CHANGING  THE  PRICE.  PRIOR  APPROVAL  BY THE COMMISSIONER SHALL NOT BE
REQUIRED FOR ANY PRICE OR CHANGE OF PRICE. HOWEVER, THE COMMISSIONER  IS
AUTHORIZED  TO MODIFY THE PRICE PER DOSE FOR ANY MEDICAL MARIHUANA PROD-
UCT IF NECESSARY TO MAINTAIN PUBLIC ACCESS TO APPROPRIATE MEDICATION.
  § 13. This act shall take effect immediately; provided, however,  that
the  amendments to title 5-A of article 33 of the public health law made
by sections one, two, three, four, five, six, seven, eight,  nine,  ten,
eleven  and twelve of this act shall not affect the repeal of such title
and shall be deemed repealed therewith. Effective immediately, the addi-
tion, amendment and/or repeal of any rule or  regulation  necessary  for
the   implementation of this act on its effective date are authorized to
be made and completed on or before such effective date.

S5657B (ACTIVE) - Details

Current Committee:: Senate Finance
Law Section:: Public Health Law
Laws Affected:: Amd Pub Health L, generally

S5657B (ACTIVE) - Summary

S5657B (ACTIVE) - Sponsor Memo

 
BILL NUMBER: S5657B

SPONSOR: SAVINO
 
TITLE OF BILL:

An act to amend the public health law, in relation to medical marihuana

 
PURPOSE OR GENERAL IDEA OF BILL:

THIS BILL ADDRESSES SEVERAL PROBLEMS WITH THE MEDICAL MARIJUANA PROGRAM.
THIS BILL CONSOLIDATES SEVERAL PROPOSALS FROM OTHER BILLS, AS WELL AS
CHANGES TO THE MEDICAL PROGRAM PROPOSED IN THE 2019 EXECUTIVE BUDGET'S
CANNABIS REGULATION AND TAXATION ACT (CRTA).

 
SUMMARY OF SPECIFIC PROVISIONS:

Section 1:  Legislative Intent

Section 2: Amends PHL § 3360 to:

*Expand eligible conditions to include any condition certified by the

practitioner;

*Allow any practitioner otherwise authorized to prescribe controlled
substances to certify patients for medical marijuana;

*Remove prohibitions on the smoking of medical marijuana; and

*Create the categories of "designated caregiver facility," "designated
caregiver facility employee," and "medical marihuana research program."

Section 3: Amends PHL § 3361 to make conforming changes. Section 4:
Amends PHL § 3362 to:

*Change possession limits from a 30 day to a 60 day supply;

*Authorize possession, acquisition, delivery, transfer, and adminis-
tration of medical marijuana by designated caregiver facilities and
their employees subject to certain requirements; and

*Prohibit smoking of medical marijuana in any place where tobacco may
not be smoked under the Clean Indoor Air Act.

Section 5: Amends PHL § 3363 to:

*Remove the $50 patient application fee for registry ID cards;

*Remove patient-per-caregiver limits when the caregiver is a designated
caregiver facility; and

*Make conforming changes Section 6: Amends PHL § 3364 to:

*Authorize registered organizations (ROs) to contract out ancillary
functions such as shipping, construction, and security; and

*Make conforming changes

Section 7: Creates a new PHL § 3364-a, "medical marihuana research
licenses," to:
*Establish a medical marijuana research license for purposes of testing,
clinical investigations, and safety and efficacy or genomic or agricul-
tural research relating to medical marijuana; and

*Details application, licensing, and oversight process.

Section 8: Creates a new PHL § 3364-b, "registration of designated care-
giver facilities," to:

*Establishes registration process for "designated caregiver facilities"
among provider types defined in section 1 of the bill; and

*Details application, registration, and oversight process. Section 9:
Creates a new PHL § 3364-c, "laboratory permits," to:

*Detail application, permitting, and oversight process. Section 10:
Amends PHL § 3365 to:

*Increase dispensaries per RO from 4 to 8; and

*Direct the Commissioner to register additional ROs reflecting the demo-
graphics of the state. Section 11: Amends PHL § 3365-a to make conform-
ing changes. Section 12: Amends PHL § 3369 to make conforming changes.

Section 13: Amends PHL § 3369-d to remove prior approval of medical
marijuana prices; maintain requirement for ROs to document price chang-
es; and maintain the commissioner's power to modify prices if necessary
to maintain access.

Section 14: Immediate effective date.  Amendments - New Section 1-
Legislative Intent - with focus on expanding the program for patients
and business opportunities for social equity applicants.  Rest of bill
is renumbered New Section 9 - adds requirement that registered organiza-
tions establishes a subsidy program to provide assistance and increase
access to patients.  New Section 10 - adds outlines the social and
economic equity plan

 
JUSTIFICATION:

Open conditions list: There is no pharmaceutical other than medical
marijuana for which the State restricts its use to a limited list of
conditions. Setting a conditions list in statute takes medical decisions
out of the hands of the practitioners who know their patients best and
whose judgment the law respects for much more dangerous drugs. Practi-
tioners also lack clarity about which conditions are actually covered.
For example, the Public Health Law definition of "severe or chronic
pain" is inconsistent with regulatory language for "severe debilitating
pain that degrades health and functional capability."

This bill would maintain the naming of several conditions in statute for
illustrative purposes, including some added in the Governor' s 2019
Cannabis Regulation and Taxation Act (CRTA), but also allows "any other
condition certified by the practitioner." While the drafting is differ-
ent, the effect is the same as 52058 of 2019.

Expanded practitioner list: Today, physicians, physician assistants, and
nurse practitioners can certify patients. However, there are other cate-
gories of practitioner outside these who are authorized to prescribe
much more dangerous substances and often treat conditions for which a
patient may be eligible (such as podiatrists and dentists whose treat-
ments involve pain medication.) This bill expands the practitioner cate-
gories to cover these groups, similar to S2056 of 2019.

Strike patient registry fees; increase supply from 30 to 60 days:
Current law requires a $50 application fee for registry identification
cards and limits patients to a 30-day supply. While the application fee
is often waived, it presents a barrier to access that does not exist for
patients with any other pharmaceutical product. Current law also limits
patients to acquiring 30-day supplies at once distances, this limits
access. The 2019 Executive budget proposed Cannabis Regulation and Taxa-
tion Act (CRTA) included both of these changes.

Allow smoking: For some patients, smoking is the most affordable deliv-
ery method and enable them to effectively limit dosage. Out of over 30
states that now have medical marijuana programs, only 4 disallow smoking
as New York does. While smoking can involve respiratory or other issues,
the quantities involved in medical marijuana use are very limited, and
should be a matter between patient and practitioner. This legislation
would protect the public by making medical marihuana smoking subject to
the Clean Indoor Air Act restrictions, similar to S490 of 2019.

Facility caregivers: Current law allows patients to designate up to two
people as caregivers under the program. Caregivers are capped at five
patients each. These caps have caused problems administering medical
marijuana in residential facilities or hospitals where there may be more
than five patients using medical marijuana for a given caregiver, or
where a patient may see more than two potential caregiver personnel
(e.g., nurses) on a regular basis. This bill authorizes, but does not
mandate, certain facilities to become "designated care giver facili-
ties," exempting them from such restrictions, similar to S2059 of 2019
and language in the CRTA.

Research licenses: While there is significant research, being done over-
seas, medical marijuana research in the United States is limited.  This
bill would facilitate medical marijuana research in New York based on
departmental regulations. Both S2059 of 2019 and the CRTA also authorize
research licenses.

Expanded lab testing: Today, the State's Wadsworth Laboratory is the
only lab authorized to test medical marijuana. As the program expands,
more lab capacity is needed. Commercial labs with Drug Enforcement Agen-
cy (DEA) licenses may be reluctant to test medical marijuana out of fear
of endangering these DEA licenses. This bill removes the requirement
that a lab which tests medical marijuana hold a DEA license and details
State permitting of labs for medical marijuana testing, similar to both
S2059 of 2019 and the CRTA.

RO contracting: Registered organizations (R0s) are currently not allowed
to contract out any part of the production and distribution processes.
This is contrary to standard business practice, is inefficient and rais-
es costs. This bill allows ROs to contract out ancillary functions, such
as security or transportation, while ensuring that laws applicable to
the RO for the purpose of those services would apply to the contractors
as well and excluding certain services directly related to the manufac-
turing process (such as trimming). This is similar to both S2059 of 2019
and the CRTA.
Increased dispensaries and ROs: Current law authorizes up to four
dispensaries for each of the 10 ROs that engages in manufacturing.  This
places New York far below every other state medical marijuana programs
for dispensary access per population. For comparison, New York has
approximately 500,000 people per dispensary versus 233,000 to 1 in Illi-
nois; 192,000 in Michigan, and 70,000 in Florida. This bill would double
the number from 4 to 8 per RO. The bill also directs the commissioner to
register additional ROs "reflecting the demographics of the state."
While current law does authorize the registration of additional ROs,
this explicit direction signals the importance of greater minority and
women-owned participation in the medical marijuana program. The dispen-
sary expansion is also found in S2059 of 2019.

Modifying price controls: Current law authorizes price setting by the
commissioner and prohibits any sale not in accordance with such prices.
In practice, ROs submit prices and price changes to the department for
approval. Since enactment, not one price setting or proposed change has
ever been rejected. But it takes weeks or even months for ROs to get
approvals, during which time they either cannot roll out new products or
cannot sell existing products at their new, typically lower prices
(nearly all price changes are downward changes; maintains reporting of
all price changes to the department; and maintains the commissioner's
authority to reject or modify prices if necessary to maintain access.

 
PRIOR LEGISLATIVE HISTORY:  New bill

 
FISCAL IMPLICATIONS:

Minimal. Minor reduction in patient registration fees ($50 each); likely
revenue increase from licensing of additional ROs and fees associated
with new license categories.

 
EFFECTIVE DATE:
Immediate.

S5657B (ACTIVE) - Bill Text download pdf


                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                 5657--B

                       2019-2020 Regular Sessions

                            I N  S E N A T E

                              May 10, 2019
                               ___________

Introduced  by  Sen.  SAVINO -- read twice and ordered printed, and when
  printed to be committed  to  the  Committee  on  Health  --  committee
  discharged, bill amended, ordered reprinted as amended and recommitted
  to said committee -- recommitted to the Committee on Health in accord-
  ance with Senate Rule 6, sec. 8 -- committee discharged, bill amended,
  ordered reprinted as amended and recommitted to said committee

AN ACT to amend the public health law, in relation to medical marihuana

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. Legislative intent. The  compassionate  care  act  provides
patients  with  necessary access to medical marihuana. While the program
has provided relief  to  numerous  patients,  several  improvements  are
necessary.   Specifically, the program has suffered from overly restric-
tive requirements regarding market participation and product regulation.
Currently, the program restricts access by only permitting  one  dispen-
sary for every 500,000 New Yorkers - leaving both urban and rural commu-
nities  drastically  underserved.  This  act  will  improve the existing
program by providing  opportunities  for  social  equity  applicants  to
participate  in the marketplace in a manner that more accurately repres-
ents the demographics  of  the  state.  Social  equity  applicants  will
include  applicants  from  communities  disproportionately  impacted  by
cannabis law enforcement.  This act will also provide  necessary  flexi-
bility  for market participants to offer products that are more accessi-
ble and affordable to some  of  New  York's  most  vulnerable  citizens.
Specifically, current restrictions on the sale of whole flower result in
medical  products  that are cost-prohibitive to many. Moreover, this act
will provide greater access to individuals who are unable to  enroll  in
the  program  including those with Alzheimer's disease and who have been
diagnosed with autism spectrum  disorder.  Much  like  the  addition  of
chronic  pain as a qualifying condition, this will allow medical practi-

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD11129-08-0

S. 5657--B                          2

tioners to recommend an alternative to addictive opiates. These  changes
will give New Yorkers access to quality care they deserve.
  §  2. Subdivisions 1, 5, 7 and 12 of section 3360 of the public health
law, subdivisions 1, 5, 7 and 12 as added by chapter 90 of the  laws  of
2014,  paragraph  (a)  of subdivision 7 as amended by chapter 273 of the
laws of 2018, are amended and three new subdivisions 5-a, 5-b and 19 are
added to read as follows:
  1. "Certified medical use" means the acquisition, possession, use, or,
transportation of medical marihuana  by  a  certified  patient,  or  the
acquisition,  possession,  delivery, transportation or administration of
medical marihuana by a designated caregiver, for  use  as  part  of  the
treatment  of  the  patient's  [serious]  condition,  as authorized in a
certification under this title including enabling the patient to  toler-
ate treatment for the [serious] condition. [A certified medical use does
not include smoking.]
  5.  "Designated  caregiver" means the individual OR CAREGIVER FACILITY
designated by a certified patient in a registry application. A certified
patient may designate up to two designated caregivers,  NOT  COUNTING  A
DESIGNATED CAREGIVER FACILITY OR DESIGNATED CAREGIVER FACILITY EMPLOYEE.
  5-A.  "DESIGNATED  CAREGIVER  FACILITY" MEANS AN ENTITY THAT REGISTERS
WITH THE COMMISSIONER TO ASSIST ONE OR MORE CERTIFIED PATIENTS WITH  THE
ACQUISITION,  POSSESSION,  DELIVERY, TRANSPORTATION OR ADMINISTRATION OF
MEDICAL MARIHUANA AND IS: A GENERAL HOSPITAL OR RESIDENTIAL HEALTH  CARE
FACILITY  OPERATING UNDER ARTICLE TWENTY-EIGHT OF THIS CHAPTER; AN ADULT
CARE FACILITY OPERATING UNDER TITLE TWO OF ARTICLE SEVEN OF  THE  SOCIAL
SERVICES  LAW;  A  COMMUNITY  MENTAL  HEALTH RESIDENCE ESTABLISHED UNDER
SECTION 41.44 OF THE MENTAL HYGIENE  LAW;  A  HOSPITAL  OPERATING  UNDER
SECTION  7.17 OF THE MENTAL HYGIENE LAW; A MENTAL HYGIENE FACILITY OPER-
ATING UNDER ARTICLE THIRTY-ONE OF THE MENTAL HYGIENE LAW;  AN  INPATIENT
OR  RESIDENTIAL  TREATMENT PROGRAM CERTIFIED UNDER ARTICLE THIRTY-TWO OF
THE MENTAL HYGIENE LAW; A RESIDENTIAL FACILITY FOR THE CARE  AND  TREAT-
MENT  OF PERSONS WITH DEVELOPMENTAL DISABILITIES OPERATING UNDER ARTICLE
SIXTEEN OF THE MENTAL HYGIENE LAW; A RESIDENTIAL TREATMENT FACILITY  FOR
CHILDREN  AND  YOUTH  OPERATING  UNDER  ARTICLE THIRTY-ONE OF THE MENTAL
HYGIENE LAW; A PUBLIC SCHOOL  OR  PRIVATE  SCHOOL  OPERATING  UNDER  THE
EDUCATION  LAW;  A RESEARCH INSTITUTION WITH AN INTERNAL REVIEW BOARD; A
MEDICAL MARIHUANA RESEARCH PROGRAM LICENSED UNDER  SECTION  THIRTY-THREE
HUNDRED  SIXTY-FOUR-A OF THIS TITLE; OR ANY OTHER FACILITY AS DETERMINED
BY THE COMMISSIONER IN REGULATION.
  5-B. "DESIGNATED CAREGIVER FACILITY EMPLOYEE" MEANS AN EMPLOYEE  OF  A
DESIGNATED CAREGIVER FACILITY.
  7. (a) ["Serious condition"] "CONDITION" means:
  (i) having one of the following [severe debilitating or life-threaten-
ing]  conditions:  cancer,  positive  status  for human immunodeficiency
virus or acquired immune deficiency syndrome, amyotrophic lateral scler-
osis, Parkinson's disease, multiple sclerosis,  damage  to  the  nervous
tissue  of  the  spinal  cord  with objective neurological indication of
intractable spasticity, epilepsy, inflammatory bowel  disease,  neuropa-
thies,  Huntington's  disease, post-traumatic stress disorder, pain that
degrades health and functional capability where the use of medical mari-
huana  is  an  alternative  to  opioid  use,  substance  use   disorder,
ALZHEIMER'S, MUSCULAR DYSTROPHY, DYSTONIA, RHEUMATOID ARTHRITIS, AUTISM,
or [as added by the commissioner; and
  (ii) any of the following conditions where it is clinically associated
with,  or  a  complication  of,  a condition under this paragraph or its
treatment: cachexia or wasting syndrome; severe or chronic pain;  severe

S. 5657--B                          3

nausea; seizures; severe or persistent muscle spasms; or such conditions
as are added by the commissioner.
  (b)  No  later  than  eighteen  months from the effective date of this
section, the commissioner shall determine whether to add  the  following
serious  conditions:  Alzheimer's,  muscular  dystrophy, dystonia, post-
traumatic stress disorder and rheumatoid arthritis] ANY OTHER  CONDITION
CERTIFIED BY THE PRACTITIONER.
  12.  "Practitioner"  means  a  practitioner  who  (i)  [is a physician
licensed by New York state and practicing within the state,] IS  AUTHOR-
IZED  TO PRESCRIBE CONTROLLED SUBSTANCES WITHIN THE STATE; (ii) [who] by
training or experience is qualified to treat a  [serious]  condition  as
defined in subdivision seven of this section; and (iii) [has completed a
two  to four hour course as determined by the commissioner in regulation
and registered with the department;  provided  however,  a  registration
shall  not  be  denied without cause. Such course may count toward board
certification requirements. The commissioner shall consider  the  inclu-
sion  of  nurse practitioners under this title based upon considerations
including access and availability. After such consideration the  commis-
sioner  is authorized to deem nurse practitioners as practitioners under
this title] COMPLETES, AT A MINIMUM, A TWO HOUR COURSE AS DETERMINED  BY
THE  COMMISSIONER.  A PERSON'S STATUS AS A PRACTITIONER UNDER THIS TITLE
IS DEEMED TO BE A "LICENSE" FOR PURPOSES OF SECTION THIRTY-THREE HUNDRED
NINETY OF THIS ARTICLE.
  19. "MEDICAL MARIHUANA RESEARCH PROGRAM"  MEANS  A  MEDICAL  MARIHUANA
RESEARCH   PROGRAM   LICENSED   UNDER   SECTION   THIRTY-THREE   HUNDRED
SIXTY-FOUR-A OF THIS TITLE.
  § 3. Subdivisions 1, 2, and 9 of section 3361  of  the  public  health
law, subdivisions 1 and 2 as added by chapter 90 of the laws of 2014 and
subdivision  9  as added by chapter 416 of the laws of 2015, are amended
to read as follows:
  1. A patient certification may only be issued if: (a)  a  practitioner
has  been  registered  with  the  department to issue a certification as
determined by the commissioner; (b) the patient has a  [serious]  condi-
tion,  which shall be specified in the patient's health care record; (c)
the practitioner by training or experience is  qualified  to  treat  the
[serious] condition; (d) the patient is under the practitioner's contin-
uing  care  for  the  [serious] condition; and (e) in the practitioner's
professional opinion and review of past treatments, the patient is like-
ly to receive therapeutic or palliative  benefit  from  the  primary  or
adjunctive  treatment  with  medical  use of marihuana for the [serious]
condition.
  2. The certification shall include (a) the name,  date  of  birth  and
address of the patient; (b) a statement that the patient has a [serious]
condition  and  the  patient  is  under  the practitioner's care for the
[serious] condition; (c) a statement attesting that all requirements  of
subdivision  one  of this section have been satisfied; (d) the date; and
(e) the name, address, federal registration  number,  telephone  number,
and  the  handwritten  signature  of  the  certifying  practitioner. The
commissioner may require by regulation that the certification  shall  be
on  a form provided by the department. The practitioner may state in the
certification that, in  the  practitioner's  professional  opinion,  the
patient  would  benefit  from  medical  marihuana only until a specified
date. The practitioner may state in the certification that, in the prac-
titioner's professional opinion, the patient is terminally ill and  that
the certification shall not expire until the patient dies.

S. 5657--B                          4

  9.(a)  A  certification may be a special certification if, in addition
to the other requirements for a certification, the  practitioner  certi-
fies  in  the  certification  that  the patient's [serious] condition is
progressive and degenerative or that delay in  the  patient's  certified
medical  use  of marihuana poses a serious risk to the patient's life or
health.
  (b) The department shall create the form to  be  used  for  a  special
certification  and  shall make that form available to be downloaded from
the department's website.
  § 4. Subdivisions 1 and 2 of section 3362 of the public health law, as
added by chapter 90 of the laws of 2014, are amended and a new  subdivi-
sion 3 is added to read as follows:
  1.  The  possession, acquisition, use, delivery, transfer, transporta-
tion, or administration of medical marihuana by a certified  patient  or
designated  caregiver  possessing  a valid registry identification card,
for certified medical use, shall be lawful under  this  title;  provided
that:
  (a)  the  marihuana that may be possessed by a certified patient shall
not exceed a [thirty] SIXTY day supply of the dosage  as  determined  by
the practitioner, consistent with any guidance and regulations issued by
the commissioner, provided that during the last seven days of any [thir-
ty]  SIXTY day period, the certified patient may also possess up to such
amount for the next [thirty] SIXTY day period;
  (b) the marihuana that may be possessed by designated caregivers  does
not  exceed the quantities referred to in paragraph (a) of this subdivi-
sion for each certified patient for whom the caregiver possesses a valid
registry identification card, up to five certified patients;
  (c) THE MARIHUANA THAT MAY BE POSSESSED BY DESIGNATED CAREGIVER FACIL-
ITIES DOES NOT EXCEED THE QUANTITIES REFERRED TO  IN  PARAGRAPH  (A)  OF
THIS  SUBDIVISION  FOR EACH CERTIFIED PATIENT UNDER CARE OR TREATMENT OF
THE FACILITY;
  (D) the form or forms of medical marihuana that may  be  possessed  by
the certified patient [or], designated caregiver, OR DESIGNATED CAREGIV-
ER  FACILITY pursuant to a certification shall be in compliance with any
recommendation or limitation by the practitioner as to the form or forms
of medical marihuana or dosage for the certified patient in the  certif-
ication; and
  [(d)]  (E) the medical marihuana shall be kept in the original package
in which it was dispensed under subdivision twelve  of  section  thirty-
three  hundred  sixty-four of this title, except for the portion removed
for immediate consumption for certified medical  use  by  the  certified
patient.
  2. Notwithstanding subdivision one of this section:
  (a)  possession  of  medical  marihuana shall not be lawful under this
title if it is smoked, consumed, vaporized, or grown in a public  place,
regardless  of  the  form  of  medical marihuana stated in the patient's
certification.
  (b) a [person] CERTIFIED PATIENT OR  DESIGNATED  CAREGIVER  possessing
medical  marihuana  under  this  title shall possess his or her registry
identification card at all times when in immediate possession of medical
marihuana.
  (C) MEDICAL MARIHUANA MAY NOT BE SMOKED IN ANY PLACE WHERE TOBACCO MAY
NOT BE SMOKED UNDER ARTICLE THIRTEEN-E OF THIS  CHAPTER,  REGARDLESS  OF
THE FORM OF MEDICAL MARIHUANA STATED IN THE PATIENT'S CERTIFICATION.
  3. THE POSSESSION, ACQUISITION, DELIVERY, TRANSFER, TRANSPORTATION, OR
ADMINISTRATION  OF  MEDICAL MARIHUANA BY A DESIGNATED CAREGIVER FACILITY

S. 5657--B                          5

OR DESIGNATED CAREGIVER FACILITY EMPLOYEE SHALL  BE  LAWFUL  UNDER  THIS
TITLE PROVIDED THAT:
  (A) THE DESIGNATED CAREGIVER FACILITY REGISTERS WITH THE DEPARTMENT ON
A FORM PROVIDED BY THE COMMISSIONER;
  (B)  SUCH POSSESSION, ACQUISITION, DELIVERY, TRANSFER, TRANSPORTATION,
OR ADMINISTRATION IS ON BEHALF  OF  A  CERTIFIED  PATIENT  POSSESSING  A
REGISTRY IDENTIFICATION CARD;
  (C) THE DESIGNATED CAREGIVER FACILITY MAINTAINS A COPY OF THE REGISTRY
IDENTIFICATION  CARD  OF  EACH CERTIFIED PATIENT FOR WHICH IT POSSESSES,
ACQUIRES, DELIVERS, TRANSFERS, TRANSPORTS, OR ADMINISTERS MEDICAL  MARI-
HUANA; AND
  (D) A DESIGNATED CAREGIVER FACILITY EMPLOYEE SHALL BE IDENTIFIED AS AN
EMPLOYEE WHEN NECESSARY, AS PROVIDED BY THE COMMISSIONER.
  § 5. Subdivisions 2, 3, 5, and 11 of section 3363 of the public health
law,  as added by chapter 90 of the laws of 2014, are amended to read as
follows:
  2. To obtain, amend or renew a registry identification card, a  certi-
fied  patient  or designated caregiver shall file a registry application
with the department. The registry  application  or  renewal  application
shall include:
  (a) in the case of a certified patient:
  (i)  the patient's certification (a new written certification shall be
provided with a renewal application);
  (ii) the name, address, and date of birth of the patient;
  (iii) the date of the certification;
  (iv) if the patient has a registry  identification  card  based  on  a
current  valid  certification,  the  registry  identification number and
expiration date of that registry identification card;
  (v) the specified date until which  the  patient  would  benefit  from
medical marihuana, if the certification states such a date;
  (vi)  the  name,  address,  federal registration number, and telephone
number of the certifying practitioner;
  (vii) any recommendation or limitation by the practitioner as  to  the
form  or forms of medical marihuana or dosage for the certified patient;
and
  (viii)  other  individual  identifying  information  required  by  the
department;
  (b)  (I) in the case of a certified patient, if the patient designates
a designated caregiver, the name, address, and  date  of  birth  of  the
designated  caregiver,  and  other  individual  identifying  information
required by the department;
  (II) IF THE DESIGNATED  CAREGIVER  IS  A  MEDICAL  MARIHUANA  RESEARCH
PROGRAM,  THE  NAME  OF  THE  ORGANIZATION  CONDUCTING THE RESEARCH; THE
ADDRESS, PHONE NUMBER, AND NAME OF THE INDIVIDUAL LEADING  THE  RESEARCH
OR  APPROPRIATE  DESIGNEE; AND OTHER IDENTIFYING INFORMATION REQUIRED BY
THE DEPARTMENT;
  (c) in the case of a designated caregiver:
  (i) the name, address, and date of birth of the designated caregiver;
  (ii) if the designated caregiver has a registry  identification  card,
the  registry identification number and expiration date of that registry
identification card; and
  (iii) other individual identifying information required by the depart-
ment;
  (d) a statement that a false statement  made  in  the  application  is
punishable under section 210.45 of the penal law;

S. 5657--B                          6

  (e)  the  date  of  the application and the signature of the certified
patient or designated caregiver, as the case may be; AND
  (f) [a fifty dollar application fee, provided, that the department may
waive or reduce the fee in cases of financial hardship; and
  (g)] any other requirements determined by the commissioner.
  3. Where a certified patient is under the age of eighteen:
  (a)  The  application for a registry identification card shall be made
by an appropriate person over twenty-one years of age.  The  application
shall state facts demonstrating that the person is appropriate.
  (b)  The  designated caregiver shall be (i) a parent or legal guardian
of the certified patient, (ii) a person designated by a parent or  legal
guardian, [or] (iii) IN THE CASE OF SUCH A CERTIFIED PATIENT BEING CARED
FOR BY A DESIGNATED CAREGIVER FACILITY, THE DESIGNATED CAREGIVER FACILI-
TY  DESIGNATED  BY  THE PARENT OR LEGAL GUARDIAN; OR (IV) an appropriate
person approved by the department upon  a  sufficient  showing  that  no
parent or legal guardian is appropriate or available.
  5.  No  person may be a designated caregiver for more than five certi-
fied patients at one time; PROVIDED HOWEVER THAT THIS  LIMITATION  SHALL
NOT  APPLY  TO  A  DESIGNATED CAREGIVER FACILITY OR DESIGNATED CAREGIVER
FACILITY EMPLOYEE.
  11. A certified patient or designated caregiver who has been issued  a
registry  identification  card shall notify the department of any change
in his or her name or address or, with respect to the patient, if he  or
she  ceases  to  have the [serious] condition noted on the certification
within ten days of such change. The certified  patient's  or  designated
caregiver's  registry  identification  card  shall be deemed invalid and
shall be returned promptly to the department.
  § 6. Subdivisions 3 and 5 of section 3364 of the public health law, as
added by chapter 90 of the laws of 2014, are amended and a new  subdivi-
sion 14 is added to read as follows:
  3.  Each  registered  organization  shall contract with an independent
laboratory PERMITTED UNDER SECTION THIRTY-THREE HUNDRED SIXTY-FOUR-C  OF
THIS  TITLE  to  test  the  medical marihuana produced by the registered
organization. The commissioner shall approve the laboratory and  require
that the laboratory report testing results in a manner determined by the
commissioner. The commissioner is authorized to issue regulation requir-
ing the laboratory to perform certain tests and services.
  5.  (a)  No  registered  organization may sell, deliver, distribute or
dispense to any certified patient or designated caregiver a quantity  of
medical  marihuana  larger  than  that  individual  would  be allowed to
possess under this title.
  (b) When dispensing medical marihuana to a certified patient or desig-
nated caregiver, the registered organization (i) shall not  dispense  an
amount  greater  than a [thirty] SIXTY day supply to a certified patient
until the certified patient has exhausted all but  a  seven  day  supply
provided  pursuant  to a previously issued certification, and (ii) shall
verify the information in subparagraph (i) of this paragraph by consult-
ing the prescription monitoring program registry under  section  thirty-
three hundred forty-three-a of this article.
  (c)  Medical  marihuana dispensed to a certified patient or designated
caregiver by a registered organization shall conform to any  recommenda-
tion  or  limitation  by  the  practitioner  as  to the form or forms of
medical marihuana or dosage for the certified patient.
  14. A REGISTERED ORGANIZATION MAY CONTRACT WITH A PERSON OR ENTITY  TO
PROVIDE  FACILITIES,  EQUIPMENT  OR  SERVICES  THAT ARE ANCILLARY TO THE
REGISTERED ORGANIZATION'S FUNCTIONS OR  ACTIVITIES  UNDER  THIS  SECTION

S. 5657--B                          7

(INCLUDING,  BUT  NOT  LIMITED  TO, SHIPPING, MAINTENANCE, CONSTRUCTION,
REPAIR, AND SECURITY),  BUT  NOT  INCLUDING  ANY  FUNCTION  OR  ACTIVITY
DIRECTLY  INVOLVING THE PLANTING, GROWING, TENDING, HARVESTING, PROCESS-
ING,  OR  PACKAGING  OF PLANTS; OR ANY OTHER FUNCTION DIRECTLY INVOLVING
MANUFACTURING OR RETAILING OF MEDICAL  MARIHUANA.  ALL  LAWS  AND  REGU-
LATIONS  APPLICABLE  TO  SUCH  FACILITIES,  EQUIPMENT, OR SERVICES SHALL
APPLY TO THE CONTRACT. THE REGISTERED ORGANIZATION AND OTHER PARTIES  TO
THE CONTRACT SHALL EACH BE RESPONSIBLE FOR COMPLIANCE WITH SUCH LAWS AND
REGULATIONS  UNDER  THE  CONTRACT. THE COMMISSIONER MAY MAKE REGULATIONS
CONSISTENT  WITH  THIS  TITLE  RELATING  TO  CONTRACTS  AND  PARTIES  TO
CONTRACTS UNDER THIS SUBDIVISION.
  §  7.  The public health law is amended by adding a new section 3364-a
to read as follows:
  § 3364-A. MEDICAL MARIHUANA RESEARCH LICENSES.   1.  THE  COMMISSIONER
SHALL  ESTABLISH  A  MEDICAL  MARIHUANA  RESEARCH LICENSE THAT PERMITS A
LICENSEE TO PRODUCE, PROCESS,  PURCHASE,  POSSESS,  TRANSFER,  AND  SELL
MARIHUANA,  SUBJECT  TO THIS SECTION, FOR THE FOLLOWING LIMITED RESEARCH
PURPOSES:
  (A) TO TEST CHEMICAL POTENCY AND COMPOSITION LEVELS;
  (B) TO CONDUCT CLINICAL INVESTIGATIONS OF MARIHUANA-DERIVED PRODUCTS;
  (C) TO CONDUCT RESEARCH ON THE EFFICACY AND  SAFETY  OF  ADMINISTERING
MARIHUANA AS PART OF MEDICAL TREATMENT; OR
  (D)  TO  CONDUCT  GENOMIC OR AGRICULTURAL RESEARCH RELATING TO MEDICAL
MARIHUANA.
  2. AS PART OF THE APPLICATION PROCESS FOR A MEDICAL MARIHUANA RESEARCH
LICENSE, AN APPLICANT MUST SUBMIT TO THE COMMISSIONER A  DESCRIPTION  OF
THE  RESEARCH  THAT IS INTENDED TO BE CONDUCTED AS WELL AS THE AMOUNT OF
MARIHUANA TO BE GROWN OR PURCHASED. THE  COMMISSIONER  SHALL  REVIEW  AN
APPLICANT'S RESEARCH PROJECT AND DETERMINE WHETHER IT MEETS THE REQUIRE-
MENTS  OF SUBDIVISION ONE OF THIS SECTION. IN ADDITION, THE COMMISSIONER
SHALL ASSESS THE APPLICATION BASED ON THE FOLLOWING CRITERIA:
  (A) PROJECT QUALITY, STUDY DESIGN, VALUE, AND IMPACT;
  (B) WHETHER THE APPLICANT HAS THE  APPROPRIATE  PERSONNEL,  EXPERTISE,
FACILITIES  AND  INFRASTRUCTURE,  FUNDING,  AND  (TO  THE EXTENT LEGALLY
AVAILABLE) APPROVALS RELATING TO HUMAN OR ANIMAL RESEARCH, IN  PLACE  TO
SUCCESSFULLY CONDUCT THE PROJECT; AND
  (C)  WHETHER  THE  AMOUNT OF MARIHUANA TO BE GROWN OR PURCHASED BY THE
APPLICANT IS CONSISTENT WITH THE PROJECT'S SCOPE AND GOALS.
  3. IF THE COMMISSIONER DETERMINES THAT THE RESEARCH PROJECT MEETS  THE
REQUIREMENTS  OF  SUBDIVISION  ONE OF THIS SECTION, THE COMMISSIONER MAY
APPROVE THE APPLICATION. IF NOT, THE APPLICATION SHALL BE DENIED.
  4. A MEDICAL MARIHUANA RESEARCH LICENSEE MAY  ONLY  SELL  OR  TRANSFER
MARIHUANA  GROWN OR PRODUCED WITHIN ITS OPERATION TO OTHER MEDICAL MARI-
HUANA RESEARCH LICENSEES, OR OTHERWISE FOR PURPOSES  OF  THE  LICENSEE'S
RESEARCH.
  5.  IN  ESTABLISHING A MEDICAL MARIHUANA RESEARCH LICENSE, THE COMMIS-
SIONER MAY MAKE REGULATIONS ON THE FOLLOWING:
  (A) APPLICATION REQUIREMENTS;
  (B)  LICENSE  RENEWAL  REQUIREMENTS,  INCLUDING   WHETHER   ADDITIONAL
RESEARCH PROJECTS MAY BE ADDED OR CONSIDERED;
  (C) CONDITIONS FOR LICENSE REVOCATION;
  (D)  SECURITY MEASURES TO ENSURE MARIHUANA IS NOT DIVERTED TO PURPOSES
OTHER THAN RESEARCH;
  (E) AMOUNT OF PLANTS, USEABLE MARIHUANA,  MARIHUANA  CONCENTRATES,  OR
MARIHUANA-INFUSED PRODUCTS A LICENSEE MAY HAVE ON ITS PREMISES;
  (F) LICENSEE REPORTING REQUIREMENTS;

S. 5657--B                          8

  (G)  CONDITIONS  UNDER WHICH MARIHUANA GROWN BY LICENSED MEDICAL MARI-
HUANA PRODUCERS AND OTHER PRODUCT TYPES FROM LICENSED MEDICAL  MARIHUANA
PROCESSORS MAY BE DONATED TO MEDICAL MARIHUANA RESEARCH LICENSEES; AND
  (H) ANY ADDITIONAL REQUIREMENTS DEEMED NECESSARY BY THE COMMISSIONER.
  6.  A  MARIHUANA  RESEARCH  LICENSE ISSUED UNDER THIS SECTION SHALL BE
ISSUED IN THE NAME OF THE APPLICANT OR APPLICANTS, SPECIFY THE  LOCATION
AT  WHICH  THE  MARIHUANA  RESEARCHER INTENDS TO OPERATE, WHICH SHALL BE
WITHIN THE STATE, AND SHALL NOT  ALLOW  ANY  OTHER  PERSON  TO  USE  THE
LICENSE EXCEPT AS UNDER SUBDIVISION FOUR OF THIS SECTION.
  7.  PARTICIPATION  BY  CERTIFIED  PATIENTS  IN  ANY  MEDICAL MARIHUANA
RESEARCH PROGRAM SHALL BE VOLUNTARY.
  8. THE APPLICATION FEE FOR A MEDICAL MARIHUANA RESEARCH LICENSE  SHALL
BE DETERMINED BY THE COMMISSIONER ON AN ANNUAL BASIS.
  9.  EACH  MEDICAL  MARIHUANA  RESEARCH  LICENSEE SHALL ISSUE AN ANNUAL
REPORT TO THE COMMISSIONER. THE COMMISSIONER SHALL  REVIEW  SUCH  REPORT
AND MAKE A DETERMINATION AS TO WHETHER THE RESEARCH PROJECT CONTINUES TO
MEET THE RESEARCH QUALIFICATIONS UNDER THIS SECTION.
  §  8.  The public health law is amended by adding a new section 3364-b
to read as follows:
  § 3364-B. REGISTRATION OF DESIGNATED  CAREGIVER  FACILITIES.    1.  TO
OBTAIN,  AMEND OR RENEW A REGISTRATION AS A DESIGNATED CAREGIVER FACILI-
TY, THE FACILITY SHALL FILE AN APPLICATION WITH  THE  COMMISSIONER.  THE
APPLICATION SHALL INCLUDE:
  (A) THE FACILITY'S FULL NAME AND ADDRESS;
  (B) OPERATING CERTIFICATE OR LICENSE NUMBER WHERE APPROPRIATE;
  (C)  NAME,  TITLE,  AND  SIGNATURE OF AN AUTHORIZED FACILITY REPRESEN-
TATIVE;
  (D) A STATEMENT THAT THE FACILITY AGREES TO SECURE AND  ENSURE  PROPER
HANDLING OF ALL MEDICAL MARIHUANA PRODUCTS;
  (E)  AN  ACKNOWLEDGEMENT  THAT A FALSE STATEMENT IN THE APPLICATION IS
PUNISHABLE UNDER SECTION 210.45 OF THE PENAL LAW; AND
  (F) ANY OTHER INFORMATION THAT MAY BE REQUIRED BY THE COMMISSIONER.
  2. PRIOR TO ISSUING OR RENEWING A DESIGNATED CAREGIVER FACILITY REGIS-
TRATION, THE COMMISSIONER MAY VERIFY THE INFORMATION  SUBMITTED  BY  THE
APPLICANT.   THE APPLICANT SHALL PROVIDE, AT THE COMMISSIONER'S REQUEST,
SUCH INFORMATION AND DOCUMENTATION, INCLUDING ANY CONSENTS  OR  AUTHORI-
ZATIONS, THAT MAY BE NECESSARY FOR THE COMMISSIONER TO VERIFY THE INFOR-
MATION.
  3.  THE APPLICATION SHALL BE APPROVED, DENIED OR DETERMINED INCOMPLETE
OR INACCURATE BY THE COMMISSIONER WITHIN THIRTY DAYS OF RECEIPT  OF  THE
APPLICATION.  IF  THE  APPLICATION  IS  APPROVED, THE COMMISSIONER SHALL
ISSUE A REGISTRATION AS SOON AS IS REASONABLY PRACTICABLE.
  4. REGISTRATIONS UNDER THIS SECTION SHALL REMAIN VALID FOR  TWO  YEARS
FROM THE DATE OF ISSUANCE.
  §  9.  The public health law is amended by adding a new section 3364-c
to read as follows:
  § 3364-C. LABORATORY PERMITS.  1. THE COMMISSIONER SHALL  APPROVE  AND
PERMIT  ONE  OR MORE INDEPENDENT LABORATORIES TO TEST MEDICAL MARIHUANA.
TO BE PERMITTED AS AN INDEPENDENT LABORATORY UNDER THIS SECTION, A LABO-
RATORY MUST APPLY TO THE DEPARTMENT IN A FORM AND MANNER  PRESCRIBED  BY
THE  COMMISSIONER AND MUST DEMONSTRATE THE FOLLOWING TO THE SATISFACTION
OF THE COMMISSIONER:
  (A) THE OWNERS AND DIRECTORS OF THE LABORATORY ARE OF GOOD MORAL CHAR-
ACTER;

S. 5657--B                          9

  (B) THE LABORATORY AND ITS  STAFF  HAVE  THE  SKILLS,  RESOURCES,  AND
EXPERTISE  NEEDED  TO  ACCURATELY  AND  CONSISTENTLY PERFORM ALL TESTING
REQUIRED;
  (C)  THE  LABORATORY HAS IN PLACE AND WILL MAINTAIN ADEQUATE POLICIES,
PROCEDURES, AND FACILITY SECURITY TO ENSURE PROPER COLLECTION, LABELING,
ACCESSIONING, PREPARATION, ANALYSIS,  RESULT  REPORTING,  DISPOSAL,  AND
STORAGE OF MEDICAL MARIHUANA;
  (D) THE LABORATORY IS PHYSICALLY LOCATED IN NEW YORK STATE;
  (E)  THE  LABORATORY HAS A CERTIFICATE OF APPROVAL AS AN ENVIRONMENTAL
LABORATORY ISSUED BY THE COMMISSIONER UNDER TITLE ONE OF ARTICLE FIVE OF
THIS CHAPTER; AND
  (F) THE LABORATORY MEETS ALL REQUIREMENTS PRESCRIBED BY  THIS  CHAPTER
AND THE COMMISSIONER IN REGULATION.
  2. THE OWNER OF AN INDEPENDENT LABORATORY PERMITTED UNDER THIS SECTION
SHALL NOT HOLD A REGISTRATION AS A REGISTERED ORGANIZATION AND SHALL NOT
HAVE ANY DIRECT OR INDIRECT OWNERSHIP INTEREST IN SUCH REGISTERED ORGAN-
IZATION.  NO BOARD MEMBER, MANAGER, OWNER, PARTNER, PRINCIPAL STAKEHOLD-
ER,  OR  MEMBER OF A REGISTERED ORGANIZATION, OR SUCH PERSON'S IMMEDIATE
FAMILY, SHALL HAVE AN INTEREST OR VOTING RIGHTS IN ANY INDEPENDENT LABO-
RATORY PERMITTEE. NO REGISTERED ORGANIZATION SHALL HAVE  ANY  DIRECT  OR
INDIRECT OWNERSHIP INTEREST IN SUCH LABORATORY.
  3.  AN  INDEPENDENT LABORATORY SHALL NOT BE REQUIRED TO BE LICENSED BY
THE FEDERAL DRUG ENFORCEMENT ADMINISTRATION.
  § 10. Subdivision 9 of section 3365 of the public health law, as added
by chapter 90 of the laws of 2014, is amended to read as follows:
  9. [The commissioner shall register no more than  five]  A  registered
[organizations]  ORGANIZATION  that  [manufacture]  MANUFACTURES medical
marihuana [with] MAY HAVE no more than  [four]  EIGHT  dispensing  sites
wholly  owned  and  operated  by  [such]  THE  registered  organization.
PROVIDED, HOWEVER, THAT ANY DISPENSING  SITE  OPENED  PURSUANT  TO  THIS
SECTION  BY  A  REGISTERED  ORGANIZATION LICENSED PRIOR TO THE EFFECTIVE
DATE OF THE CHAPTER OF THE LAWS OF TWO THOUSAND TWENTY THAT AMENDED THIS
SUBDIVISION SHALL NOT BE APPROVED BY THE DEPARTMENT  UNTIL  SUCH  REGIS-
TERED  ORGANIZATIONS ESTABLISHES A SUBSIDY PROGRAM TO PROVIDE ASSISTANCE
AND INCREASE ACCESS TO PATIENTS. The commissioner shall ensure that such
[registered  organizations  and]  dispensing  sites  are  geographically
distributed  across the state. The commission [may] SHALL register addi-
tional registered  organizations  REFLECTING  THE  DEMOGRAPHICS  OF  THE
STATE.
  (A)  THE  DEPARTMENT SHALL IMPLEMENT A SOCIAL AND ECONOMIC EQUITY PLAN
AND ACTIVELY PROMOTE APPLICATIONS  FROM  COMMUNITIES  DISPROPORTIONATELY
IMPACTED  BY CANNABIS PRODUCTION, AND PROMOTE RACIAL, ETHNIC, AND GENDER
DIVERSITY WHEN ISSUING  THE  ADDITIONAL  FOUR  REGISTERED  ORGANIZATIONS
LICENSES,  INCLUDING  BY  PRIORITIZING  CONSIDERATION OF APPLICATIONS BY
APPLICANTS WHO ARE FROM COMMUNITIES DISPROPORTIONATELY IMPACTED  BY  THE
ENFORCEMENT  OF  CANNABIS  PROHIBITION OR WHO QUALIFY AS A MINORITY OR A
WOMEN-OWNED BUSINESS. SUCH QUALIFICATIONS SHALL  BE  DETERMINED  BY  THE
DEPARTMENT IN REGULATION.
  (B) THE DEPARTMENT SHALL ISSUE FOUR ADDITIONAL REGISTERED ORGANIZATION
LICENSES  AND CREATE A SOCIAL AND ECONOMIC EQUITY PLAN TO PROMOTE DIVER-
SITY IN OWNERSHIP AND EMPLOYMENT IN THE MEDICAL MARIHUANA  INDUSTRY  AND
ENSURE INCLUSION OF:
  (I)  INDIVIDUALS  FROM  COMMUNITIES DISPROPORTIONATELY IMPACTED BY THE
ENFORCEMENT OF CANNABIS PROHIBITION;
  (II) MINORITY-OWNED BUSINESSES;
  (III) WOMEN-OWNED BUSINESSES;

S. 5657--B                         10

  (IV) MINORITY AND WOMEN-OWNED BUSINESSES, AS DEFINED IN PARAGRAPH  (D)
OF THIS SUBDIVISION; AND
  (C)  THE  SOCIAL AND ECONOMIC EQUITY PLAN SHALL REQUIRE AN ANALYSIS OF
HOW TO PRIORITIZE OPPORTUNITIES FOR APPLICANTS THAT ARE:
  (I) A MEMBER OF A COMMUNITY GROUP  THAT  HAS  BEEN  DISPROPORTIONATELY
IMPACTED BY THE ENFORCEMENT OF CANNABIS PROHIBITION;
  (II)  WAS  CONVICTED OF A CANNABIS-RELATED OFFENSE PRIOR TO THE EFFEC-
TIVE DATE OF THE CHAPTER OF THE LAWS OF TWO THOUSAND TWENTY THAT AMENDED
THIS SUBDIVISION, OR HAD A PARENT, GUARDIAN, CHILD, SPOUSE,  OR  DEPEND-
ENT,  OR  WAS  A  DEPENDENT OF AN INDIVIDUAL WHO, PRIOR TO THE EFFECTIVE
DATE OF THE CHAPTER OF THE LAWS OF TWO THOUSAND TWENTY THAT AMENDED THIS
SUBDIVISION, WAS CONVICTED OF A CANNABIS-RELATED OFFENSE.
  (D) FOR THE PURPOSES OF THIS SECTION, THE FOLLOWING DEFINITIONS  SHALL
APPLY:
  (I)  "MINORITY-OWNED  BUSINESS"  SHALL  MEAN  A  BUSINESS  ENTERPRISE,
INCLUDING A SOLE PROPRIETORSHIP, PARTNERSHIP, LIMITED LIABILITY  COMPANY
OR CORPORATION THAT IS:
  (1)  AT  LEAST  FIFTY-ONE  PERCENT OWNED BY ONE OR MORE MINORITY GROUP
MEMBERS;
  (2) AN ENTERPRISE IN WHICH SUCH MINORITY OWNERSHIP IS  REAL,  SUBSTAN-
TIAL AND CONTINUING;
  (3)  AN  ENTERPRISE IN WHICH SUCH MINORITY OWNERSHIP HAS AND EXERCISES
THE AUTHORITY TO CONTROL INDEPENDENTLY THE DAY-TO-DAY BUSINESS DECISIONS
OF THE ENTERPRISE;
  (4) AN ENTERPRISE AUTHORIZED TO DO BUSINESS IN THIS  STATE  AND  INDE-
PENDENTLY OWNED AND OPERATED; AND
  (5) AN ENTERPRISE THAT IS A SMALL BUSINESS.
  (II)  "MINORITY  GROUP  MEMBER"  SHALL MEAN A UNITED STATES CITIZEN OR
PERMANENT RESIDENT ALIEN WHO IS AND CAN DEMONSTRATE MEMBERSHIP IN ONE OF
THE FOLLOWING GROUPS:
  (1) BLACK PERSONS HAVING ORIGINS IN ANY OF THE  BLACK  AFRICAN  RACIAL
GROUPS;
  (2)  HISPANIC  PERSONS  OF  MEXICAN,  PUERTO  RICAN, DOMINICAN, CUBAN,
CENTRAL OR SOUTH AMERICAN OF EITHER INDIAN OR HISPANIC  ORIGIN,  REGARD-
LESS OF RACE;
  (3) NATIVE AMERICAN OR ALASKAN NATIVE PERSONS HAVING ORIGINS IN ANY OF
THE ORIGINAL PEOPLES OF NORTH AMERICA; OR
  (4)  ASIAN  AND  PACIFIC ISLANDER PERSONS HAVING ORIGINS IN ANY OF THE
FAR EAST COUNTRIES, SOUTH EAST ASIA,  THE  INDIAN  SUBCONTINENT  OR  THE
PACIFIC ISLANDS.
  (III) "WOMEN-OWNED BUSINESS" SHALL MEAN A BUSINESS ENTERPRISE, INCLUD-
ING  A  SOLE  PROPRIETORSHIP,  PARTNERSHIP, LIMITED LIABILITY COMPANY OR
CORPORATION THAT IS:
  (1) AT LEAST FIFTY-ONE PERCENT OWNED BY  ONE  OR  MORE  UNITED  STATES
CITIZENS OR PERMANENT RESIDENT ALIENS WHO ARE WOMEN;
  (2)  AN  ENTERPRISE  IN  WHICH THE OWNERSHIP INTEREST OF SUCH WOMEN IS
REAL, SUBSTANTIAL AND CONTINUING;
  (3) AN ENTERPRISE IN WHICH SUCH WOMEN OWNERSHIP HAS AND EXERCISES  THE
AUTHORITY  TO CONTROL INDEPENDENTLY THE DAY-TO-DAY BUSINESS DECISIONS OF
THE ENTERPRISE;
  (4) AN ENTERPRISE AUTHORIZED TO DO BUSINESS IN THIS  STATE  AND  INDE-
PENDENTLY OWNED AND OPERATED; AND
  (5) AN ENTERPRISE THAT IS A SMALL BUSINESS.
  (IV) "A FIRM OWNED BY A MINORITY GROUP MEMBER WHO IS ALSO A WOMAN" MAY
INCLUDE A MINORITY-OWNED BUSINESS, A WOMEN-OWNED BUSINESS, OR BOTH.

S. 5657--B                         11

  (V)  "COMMUNITIES  DISPROPORTIONATELY IMPACTED" SHALL MEAN, BUT NOT BE
LIMITED TO, A HISTORY OF ARRESTS, CONVICTIONS, AND OTHER LAW ENFORCEMENT
PRACTICES IN A CERTAIN GEOGRAPHIC AREA, SUCH  AS,  BUT  NOT  LIMITED  TO
PRECINCTS,   ZIP   CODES,  NEIGHBORHOODS,  AND  POLITICAL  SUBDIVISIONS,
REFLECTING  A  DISPARATE  ENFORCEMENT  OF  CANNABIS PROHIBITION DURING A
CERTAIN TIME PERIOD, WHEN COMPARED TO  THE  REST  OF  THE  STATE.    THE
DEPARTMENT  SHALL  ISSUE  GUIDELINES  TO  DETERMINE  HOW TO ASSESS WHICH
COMMUNITIES HAVE BEEN DISPROPORTIONATELY IMPACTED AND HOW TO  ASSESS  IF
SOMEONE IS A MEMBER OF A COMMUNITY DISPROPORTIONATELY IMPACTED.
  (E)  THE    DEPARTMENT  SHALL  ACTIVELY PROMOTE APPLICANTS THAT FOSTER
RACIAL, ETHNIC, AND GENDER DIVERSITY IN THEIR WORKFORCE.
  § 11. Subdivision 1 of section 3365-a of the  public  health  law,  as
added by chapter 416 of the laws of 2015, is amended to read as follows:
  1.  There is hereby established in the department an emergency medical
marihuana access program (referred to in this section as the  "program")
under this section. The purpose of the program is to expedite the avail-
ability of medical marihuana to avoid suffering and loss of life, during
the  period  before  full  implementation  of  and production under this
title, especially in the case of patients whose [serious]  condition  is
progressive  and  degenerative  or  is  such that delay in the patient's
medical use of marihuana poses a serious risk to the patient's  life  or
health. The commissioner shall implement the program as expeditiously as
practicable, including by emergency regulation.
  § 12. Subdivision 1 of section 3369 of the public health law, as added
by chapter 90 of the laws of 2014, is amended to read as follows:
  1.  Certified  patients,  designated  caregivers, DESIGNATED CAREGIVER
FACILITIES, DESIGNATED CAREGIVER FACILITY EMPLOYEES,  MEDICAL  MARIHUANA
RESEARCH  PROGRAM EMPLOYEES, practitioners, registered organizations and
the employees of  registered  organizations  shall  not  be  subject  to
arrest,  prosecution,  or  penalty in any manner, or denied any right or
privilege, including but not limited to civil  penalty  or  disciplinary
action  by a business or occupational or professional licensing board or
bureau, solely for the certified medical use or manufacture of  marihua-
na, or for any other action or conduct in accordance with this title.
  §  13. Section 3369-d of the public health law, as added by chapter 90
of the laws of 2014, is amended to read as follows:
  § 3369-d. Pricing. [1. Every sale of medical marihuana shall be at the
price determined by the commissioner. Every charge made or demanded  for
medical  marihuana  not  in  accordance with the price determined by the
commissioner, is prohibited.
  2. The commissioner is hereby authorized to set the per dose price  of
each  form  of medical marihuana sold by any registered organization. In
setting the per dose price  of  each  form  of  medical  marihuana,  the
commissioner  shall  consider  the fixed and variable costs of producing
the form of marihuana and any other factor the commissioner, in  his  or
her discretion, deems relevant to determining the per dose price of each
form  of  medical  marihuana.]  REGISTERED  ORGANIZATIONS  SHALL  SUBMIT
DOCUMENTATION OF ANY PRICE AND CHANGE IN PRICE PER DOSE FOR ANY  MEDICAL
MARIHUANA  PRODUCT TO THE COMMISSIONER WITHIN FIFTEEN DAYS OF SETTING OR
CHANGING THE PRICE. PRIOR APPROVAL BY  THE  COMMISSIONER  SHALL  NOT  BE
REQUIRED  FOR ANY PRICE OR CHANGE OF PRICE. HOWEVER, THE COMMISSIONER IS
AUTHORIZED TO MODIFY THE PRICE PER DOSE FOR ANY MEDICAL MARIHUANA  PROD-
UCT IF NECESSARY TO MAINTAIN PUBLIC ACCESS TO APPROPRIATE MEDICATION.
  §  14. This act shall take effect immediately; provided, however, that
the amendments to title 5-A of article 33 of the public health law  made
by  sections two, three, four, five, six, seven, eight, nine, ten, elev-

S. 5657--B                         12

en, twelve and thirteen of this act shall not affect the repeal of  such
title and shall be deemed repealed therewith. Effective immediately, the
addition,  amendment  and/or  repeal of any rule or regulation necessary
for the  implementation of this act on its effective date are authorized
to be made and completed on or before such effective date.

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The New York State Senate

senate Bill S5657B

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Archive: Last Bill Status - In Senate Committee Finance Committee

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Mar 10, 2020 - Health committee Vote

Health Committee Vote: Mar 10, 2020

Bill Amendments

S5657 - Details

S5657 - Summary

S5657 - Sponsor Memo

S5657 - Bill Text download pdf

S5657A - Details

S5657A - Summary

S5657A - Sponsor Memo

S5657A - Bill Text download pdf

S5657B (ACTIVE) - Details

S5657B (ACTIVE) - Summary

S5657B (ACTIVE) - Sponsor Memo

S5657B (ACTIVE) - Bill Text download pdf

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senate Bill S5657B

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Diane J. Savino

Archive: Last Bill Status - In Senate Committee Finance Committee

Your Voice

Actions

Votes

Mar 10, 2020 - Health committee Vote

Health Committee Vote: Mar 10, 2020

Bill Amendments

S5657 - Details

S5657 - Summary

S5657 - Sponsor Memo

S5657 - Bill Text download pdf

S5657A - Details

S5657A - Summary

S5657A - Sponsor Memo

S5657A - Bill Text download pdf

S5657B (ACTIVE) - Details

S5657B (ACTIVE) - Summary

S5657B (ACTIVE) - Sponsor Memo

S5657B (ACTIVE) - Bill Text download pdf

Comments